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Clinical Trials/NCT03878667
NCT03878667
Completed
Not Applicable

Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program

Texas A&M University0 sites240 target enrollmentJanuary 1, 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet Modification
Sponsor
Texas A&M University
Enrollment
240
Primary Endpoint
Energy Homeostasis: Resting Energy Expenditure (REE)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

Detailed Description

The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise \& Sport Nutrition Lab at Texas A\&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.

Registry
clinicaltrials.gov
Start Date
January 1, 2004
End Date
December 31, 2005
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard B. Kreider

Executive Director, Human Clinical Research Facility

Texas A&M University

Eligibility Criteria

Inclusion Criteria

  • Participant is female;
  • Participant is post-menopausal;
  • Participant is between the ages of 45 and 65;
  • Participant is sedentary, overweight (BMI \> 27) and post-menopausal;

Exclusion Criteria

  • Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
  • Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
  • Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
  • Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.g., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
  • Participant is consistently taking 500 mg or more of a Calcium supplement per day;
  • Participant is receiving Hormone Replacement Therapy (HRT);
  • Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study;
  • Participant has lost \> 20 lbs. within the last 3 - 6 months;

Outcomes

Primary Outcomes

Energy Homeostasis: Resting Energy Expenditure (REE)

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)

Body Composition: Body Fat

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Body Composition: Fat Free Mass

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Body Composition: Bone Mass

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Body Composition: Lean Mass

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Body Composition: Fat Mass

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Energy Homeostasis: Respiratory Exchange Ratio (RER)

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in 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 with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)

Body Composition: Body Weight

Time Frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks

Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

Secondary Outcomes

  • Comprehensive Metabolic Panel - CMP: Amino Transferase (AST)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Muscular Strength: 1 Repetition Maximum (1RM) Leg Press(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Lipid Panel: Cholesterol(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Lipid Panel: HDL Cholesterol(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Calcium(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Carbon Dioxide (CO2)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Glucose(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Total Protein(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Muscular Strength: 1 Repetition Maximum (1RM) Bench Press(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Body Composition: Body Water(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Lipid Panel: LDL Cholesterol(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Lipid Panel: Triglycerides(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Albumin(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Sodium(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Potassium(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Creatinine(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Amino Transferase (ALT)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Hemoglobin(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Lymphocytes(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Basophils(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Hormones: Leptin(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Chloride(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Blood Urea Nitrogen (BUN)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Alkaline Phosphatase (ALP)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Comprehensive Metabolic Panel - CMP: Bilirubin(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: White Blood Cell (WBC) Count(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Hematocrit(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Platelet Count(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Mean Platelet Volume (MPV)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Red Blood Cell (RBC) Count(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Red Cell Distribution Width (RDW)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: White Blood Cell Differential(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Neutrophils(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Eosinophils(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Mean Corpuscular Hemoglobin (MCH)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Monocytes(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Hormones: Insulin(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Mean Corpuscular Volume (MCV)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Complete Blood Count - CBC: Mean Corpuscular Hemoglobin Concentration (MCHC)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Hemodynamic Variable: Resting Heart Rate (HR)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Anthropometric Measures: Waist to Hip Ratio(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Cardiac Variable: Resting Electrocardiogram (ECG)(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Subjective Rating of Amount of Energy(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Dietary Energy Intake - Total Caloric Intake(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Anthropometric Measures: Waist Circumference(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Anthropometric Measures: Hip Circumference(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Anthropometric Measures: Body Mass Index(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Exercise Capacity: Graded Exercise Test (GXT)(Measured prior to supplementation (Pre), after 10 weeks and 14 weeks)
  • Subjective Rating of Appetite(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Subjective Rating of Satisfaction from Food(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Dizziness(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Subjective Rating of Quality of Life(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Subjective Rating of Feelings of Fullness(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Dietary Energy Intake - Carbohydrate(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Dietary Energy Intake - Fat(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Subjective Rating of Hunger(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Subjective Rating of Overall Quality of Diet(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Dietary Energy Intake - Protein(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Blurred Vision(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Other Side Effects(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Headache(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Tachycardia(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Palpitations(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Dyspnea(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)
  • Perceptions of Side Effects - Nervousness(Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks)

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