Persea Americana for Total Health (PATH ) Study
- Conditions
- Insulin ResistanceInsulin SensitivityObesity, Abdominal
- Interventions
- Other: AvocadoOther: Control
- Registration Number
- NCT02740439
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- Brief Summary
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.
- Detailed Description
The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Males and females
- Between the ages of 25-45 years at the time of consent
- Body mass index ≥27.5kg/m2
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- Ability to drop-off fecal sample within 15 minutes of defecation
- Current pregnancy or lactation
- Tobacco use
- Avocado allergy or intolerance
- Food allergies, lactose intolerance
- Latex allergy
- Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
- Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking
- Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
- Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
- High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
- Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Meal Avocado Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks. Control Meal Control Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Abdominal obesity Baseline, 4 weeks, 8 weeks, 12 weeks Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.
Insulin Resistance Baseline, 4 weeks, 8 weeks, 12 weeks Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.
Glycemic Control Baseline, 4 weeks, 8 weeks,12 weeks Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.
Insulin Sensitivity Baseline, 12 weeks Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.
- Secondary Outcome Measures
Name Time Method Gastrointestinal Microbiota Composition and Short Chain Fatty Acids Baseline, 4 weeks, 8 weeks, 12 weeks Microbial taxonomy will be assessed using high throughput sequencing and short chain fatty acids will be quantified using gas chromatography and mass spectrometry.
Inflammatory Markers Baseline, 12 weeks Markers of inflammation such as c-reactive protein (CRP) will be assessed using venous blood samples.
Blood Lipid Panel Baseline, 12 weeks Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides will be assessed using venous blood samples.
Sleep and Fatigue Baseline, 12 weeks Sleep and fatigue will be evaluated using the Pittsburgh Sleep Quality Index
Physical Activity Baseline, 12 weeks Physical activity will be measured over 7 day periods by a waist mounted accelerometer.
Cognitive Function Baseline, 4 weeks, 8 weeks, 12 weeks Cognitive function will be evaluated using tasks that measure prefrontal cognitive control and hippocampal relational memory networks.
Retinal Lutein Baseline, 4 weeks, 8 weeks, 12 weeks Retinal lutein will be assessed using Macular Pigment Optical Density.
Serum Lutein Baseline, 12 weeks Serum lutein will be assessed using venous blood samples.
Resting Energy Expenditure Baseline, 12 weeks REE will be measured by indirect calorimetry.
DNA Analyses Baseline Genetic markers related to obesity and cognitive function will be assessed using blood samples to determine the mediating effects of genetics on changes related to study outcomes.
Dietary Intake Baseline, 4 weeks, 8 weeks, 12 weeks Dietary intake will be evaluated using 7 day diet records at baseline, 4, 8, and 12 weeks and by NCI NHANES 30-day food frequency questionnaires at baseline and 12 weeks.
Blood Pressure Baseline, 12 weeks Blood pressure will be measured using an automatic blood pressure cuff.
Neuroelectric Assessment Baseline, 4 weeks, 8 weeks, 12 weeks A Neuroelectric Assessment will be conducted during cognitive tasks using an Electroencephalogram (EEG) amplifier.
Liver Enzymes Baseline, 12 weeks Liver enzymes will be assessed using venous blood samples.
Trial Locations
- Locations (1)
University of Illinois, Urbana-Champaign
🇺🇸Urbana, Illinois, United States