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An Examination of a Weight Loss Formula on Health

Not Applicable
Completed
Conditions
Weight Loss
Interventions
Dietary Supplement: Placebo
Dietary Supplement: Active with caffeine
Dietary Supplement: Active without caffeine
Registration Number
NCT03395262
Lead Sponsor
Texas A&M University
Brief Summary

The aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Detailed Description

Obesity remains a problem for overall health and risk for cardiovascular disease worldwide. While dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. A potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. However, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. Therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Body Mass Index (BMI) between 25 and 34.9
Exclusion Criteria
  • Recent history of weight change (+/- 10 lbs. within the past 3 months)
  • Uncontrolled metabolic disorders
  • Uncontrolled cardiovascular disorders
  • Currently taking prescription medications (birth control is allowed)
  • Currently taking dietary supplements for weight loss
  • Pregnant or plan to become pregnant
  • Have an intolerance to caffeine or other natural stimulants

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboDextrose
Active with caffeineActive with caffeineNovel formula with caffeine
Active without caffeineActive without caffeineNovel formula without caffeine
Primary Outcome Measures
NameTimeMethod
Body Composition - Fat MassMeasured every 4 weeks for 12 weeks

Changes in fat mass (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Body Composition - WeightMeasured every 4 weeks for 12 weeks

Changes in body weight (kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Body Composition - Body Fat PercentMeasured every 4 weeks for 12 weeks

Changes in body fat (%) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Secondary Outcome Measures
NameTimeMethod
Body Composition - Fat Free MassMeasured every 4 weeks for 12 weeks

Changes in fat free mass (sum of lean tissue mass and bone mass expressed in kg) analyzed with related body composition variables via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Body Composition - Total Body WaterMeasured every 4 weeks for 12 weeks

Change in total body water (L and %) and analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Dietary Energy Intake - CarbohydrateMeasured every 4 weeks for 12 weeks

Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Resting Hemodynamics - Systolic Blood PressureMeasured every 4 weeks for 12 weeks

Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Glucose Homeostasis - Blood GlucoseMeasured every 4 weeks for 12 weeks

Change in blood glucose (mg/dl) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Alanine Amino TransaminaseMeasured every 4 weeks for 12 weeks

Change in alanine amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - White Blood Cell Counts - Mid-Range CountMeasured every 4 weeks for 12 weeks

Change in mid-range count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - HematocritMeasured every 4 weeks for 12 weeks

Change in hematocrit (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Body Composition - Lean Tissue MassMeasured every 4 weeks for 12 weeks

Change in lean tissue mass (kg) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Body Composition - Bone MassMeasured every 4 weeks for 12 weeks

Change in bone mass (g) analyzed with related body composition outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Resting Energy Expenditure - Caloric ExpenditureMeasured every 4 weeks for 12 weeks

Change in resting energy expenditure expressed in absolute (kcals/d) and relative terms (kcals/kg/day) and analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Anthropometric Measures - Hip CircumferenceMeasured every 4 weeks for 12 weeks

Change in hip circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Anthropometric Measures - Waist to Hip RatioMeasured every 4 weeks for 12 weeks

Change in the ratio of waist to hip (waist / hip circumference) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Resting Energy Expenditure - Respiratory Exchange RatioMeasured every 4 weeks for 12 weeks

Change in resting respiratory exchange ratio (RER) as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Anthropometric Measures - Waist CircumferenceMeasured every 4 weeks for 12 weeks

Change in waist circumference (cm) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Resting Hemodynamics - Diastolic Blood PressureMeasured every 4 weeks for 12 weeks

Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Anthropometric Measures - Body Mass IndexMeasured every 4 weeks for 12 weeks

Change in body mass index (kg of body mass / height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Dietary Energy Intake - Total Caloric IntakeMeasured every 4 weeks for 12 weeks

Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Dietary Energy Intake - FatMeasured every 4 weeks for 12 weeks

Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Resting Hemodynamics - Heart RateMeasured every 4 weeks for 12 weeks

Changes in resting heart rate (bpm) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Glucose Homeostasis - Fasting InsulinMeasured every 4 weeks for 12 weeks

Change in fasting insulin (µIU/mL) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Glucose Homeostasis - Homeostatic Model Assessment of Insulin ResistanceMeasured every 4 weeks for 12 weeks

Change in Homeostatic Model Assessment of Insulin Resistance (Fasting insulin x Fasting glucose / 405) analyzed with related glucose homeostasis blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Lipid Profile - Total CholesterolMeasured every 4 weeks for 12 weeks

Change in total cholesterol (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Lipid Profile - Total Cholesterol to HDL RatioMeasured every 4 weeks for 12 weeks

Change in the ratio of total cholesterol to high density lipoproteins (HDL) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - CreatinineMeasured every 4 weeks for 12 weeks

Change in creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea NitrogenMeasured every 4 weeks for 12 weeks

Change in blood urea nitrogen (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - White Blood Cell Counts - White Blood CellsMeasured every 4 weeks for 12 weeks

Change in white blood cells (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Dietary Energy Intake - ProteinMeasured every 4 weeks for 12 weeks

Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Lipid Profile - TriglyderidesMeasured every 4 weeks for 12 weeks

Change in triglycerides (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Lipid Profile - High Density LipoproteinsMeasured every 4 weeks for 12 weeks

Change in high density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Lipid Profile - Low Density LipoproteinsMeasured every 4 weeks for 12 weeks

Change in low density lipoproteins (mg/dl) analyzed with related lipid profile blood chemistry markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Blood Urea Nitrogen to Creatinine RatioMeasured every 4 weeks for 12 weeks

Change in the ratio of blood urea nitrogen (mg/dl) to creatinine (mg/dl) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Alkaline PhosphataseMeasured every 4 weeks for 12 weeks

Change in alkaline phosphatase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Creatine KinaseMeasured every 4 weeks for 12 weeks

Change in creatine kinase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Lactate DehydrogenaseMeasured every 4 weeks for 12 weeks

Change in lactate dehydrogenase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Catabolic Markers - Aspartate Amino TransaminaseMeasured every 4 weeks for 12 weeks

Change in aspartate amino transaminase (IU/L) analyzed with related blood chemistry catabolic markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular VolumeMeasured every 4 weeks for 12 weeks

Change in mean corpuscular volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

International Physical Activity Questionnaire (IPAQ) - Total Physical Activity ScoreMeasured every 4 weeks for 12 weeks

Change in IPAQ leisure time domain (Total physical activity MET-minutes/week = sum of Total Work + Total Transport + Total Domestic and Garden + Total Leisure-Time MET-minutes/week scores) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Satiety Questionnaire - Perceptions of HungerMeasured every 4 weeks for 12 weeks

Changes in perceptions of hunger assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - White Blood Cell Counts - LymphocytesMeasured every 4 weeks for 12 weeks

Change in lymphocytes (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - White Blood Cell Counts - GranulocyteMeasured every 4 weeks for 12 weeks

Change in granulocyte count (K/uL) analyzed with related white blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Red CellsMeasured every 4 weeks for 12 weeks

Change in red cell count (M/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - HemoglobinMeasured every 4 weeks for 12 weeks

Change in hemoglobin (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular HemoglobinMeasured every 4 weeks for 12 weeks

Change in mean corpuscular hemoglobin (pg/cell) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Corpuscular Hemoglobin ConcentrationMeasured every 4 weeks for 12 weeks

Change in mean corpuscular hemoglobin concentration (g/dl) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Appetite Hormone - LeptinMeasured every 4 weeks for 12 weeks

Change in leptin levels (ng/ml) analyzed via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

International Physical Activity Questionnaire (IPAQ) - Work DomainMeasured every 4 weeks for 12 weeks

Change in IPAQ work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Satiety Questionnaire - Perceptions of AppetiteMeasured every 4 weeks for 12 weeks

Changes in perceptions of appetite assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Satiety Questionnaire - Perceptions of Feelings of FullnessMeasured every 4 weeks for 12 weeks

Changes in perceptions of feelings of fullness assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Red Cell Distribution WidthMeasured every 4 weeks for 12 weeks

Change in red cell distribution width (%) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Platelet CountMeasured every 4 weeks for 12 weeks

Change in platelet count (x103/uL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Blood Chemistry Markers of Health - Red Blood Cell Counts - Mean Platelet VolumeMeasured every 4 weeks for 12 weeks

Change in mean platelet volume (fL) analyzed with related red blood cell count markers of health via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

International Physical Activity Questionnaire (IPAQ) - Active Transportation DomainMeasured every 4 weeks for 12 weeks

Change in IPAQ active transportation domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

International Physical Activity Questionnaire (IPAQ) - Domestic and Garden/Yard Work DomainMeasured every 4 weeks for 12 weeks

Change in IPAQ domestic and garden/yard work domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

International Physical Activity Questionnaire (IPAQ) - Leisure-Time DomainMeasured every 4 weeks for 12 weeks

Change in IPAQ leisure-time domain (MET minutes/week) analyzed with related IPAQ outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Satiety Questionnaire - Perceptions of Satisfaction with FoodMeasured every 4 weeks for 12 weeks

Changes in perceptions of satisfaction with food assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Sleep Quality Questionnaire - Sleep QualityMeasured every 4 weeks for 12 weeks

Changes in rating of sleep quality over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Sleep Quality Questionnaire - EnthusiasmMeasured every 4 weeks for 12 weeks

Changes in rating of enthusiasm over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - Other Side EffectsMeasured every 4 weeks for 12 weeks

Change in perceptions of other side effects using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Satiety Questionnaire - Perceptions of Diet / Eating SatisfactionMeasured every 4 weeks for 12 weeks

Changes in perceptions of diet / eating satisfaction assessed using using a 0 to 10 Likert scale (0 was none, 2.5 was low, 5 was moderate, and 7.5 was high, and 10 was severe) and analyzed with related satiety questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - TachycardiaMeasured every 4 weeks for 12 weeks

Change in perceptions of tachycardia using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - DyspneaMeasured every 4 weeks for 12 weeks

Change in perceptions of dyspnea using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - NervousnessMeasured every 4 weeks for 12 weeks

Change in perceptions of nervousness using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Sleep Quality Questionnaire - Sleep DurationMeasured every 4 weeks for 12 weeks

Changes in average reported sleep duration over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - DizzinessMeasured every 4 weeks for 12 weeks

Change in perceptions of dizziness using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - HeadacheMeasured every 4 weeks for 12 weeks

Change in perceptions of headache using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - PalpitationsMeasured every 4 weeks for 12 weeks

Change in perceptions of palpitations using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Sleep Quality Questionnaire - Sleep DisturbancesMeasured every 4 weeks for 12 weeks

Changes in rating of sleep disturbances over the prior 48 hours analyzed with related sleep quality questionnaire outcomes via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Perceptions of Side Effects - Blurred VisionMeasured every 4 weeks for 12 weeks

Change in perceptions of blurred vision using a Likert scale \[0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe)\] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses and mean changes from baseline with 95% confidence intervals (CI's).

Trial Locations

Locations (1)

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

🇺🇸

College Station, Texas, United States

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