Body Weight, Overweight or Obesity
Conditions
Brief summary
The proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.
Detailed description
A total of 93 males and females will participate in the study at the University of Toronto. At the beginning and after 12 weeks, body weight, composition will be measured through Bodpod scans. Resting metabolic rate and thermogenesis will be measured by indirect calorimetry. Also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, HbA1c, short-chain fatty acid, red blood cells and FGF21. Urine samples will be collected throughout the study. A followup session at 16 weeks will reassess previous measures.
Interventions
OTHERDairy-based commercially available food products
Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
OTHERRestrictive Eating
Dietitian will assist with 500 kcal/day reduction through limiting of macronutrients 45-65% energy from carbohydrates 20-35% energy from fat 10-35% energy from protein
Sponsors
Mount Saint Vincent University
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI: ≥ 27 and ≤ 34.9 kg/m2 * Fasting serum glucose: ≤ 7 mmol/L * Low ≤1 serving of dairy consumption * Waist circumference \>88cm (women) and \>102cm (men) * Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. * Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit. * Willing to abstain from alcohol consumption for 24 h prior to all test visits. * Willing to avoid vigorous physical activity for 24 h prior to all test visits. * Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
Exclusion criteria
* Fasting blood glucose \> 7 mmol/L * Triglycerides ≥ 2.3 mmol/L * Smoking tobacco products and marijuana * Thyroid problems * Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease. * Presence of gastrointestinal disorder or surgeries within the past year. * Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement. * Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months. * Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal * Unwillingness or inability to comply with the experimental procedures * Known intolerance, sensitivity or allergy to dairy products * Consumption of protein powders/protein supplements * Extreme dietary habits * Uncontrolled hypertension as defined by the average blood pressure measured at screening. * Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity * Excessive alcohol intake * Restrained Eaters
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Starting at the beginning of the study 0 week then biweekly for 7 sessions up to 12 weeks with a followed up at 16 weeks. | Each participant will attend 8 sessions biweekly in total |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood glucose levels | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in fasting insulin (µIU/mL) levels in the blood | Change from baseline at 12 weeks | Each participant will attend 3 sessions in total |
| Change in gut hormone levels measured in the blood | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in triacylglycerol level (mg/dL) | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in HbA1c (mmol/mol) | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Fecal Collection | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Gut microbiome profiling |
| Change in resting metabolic rate | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total measured by Indirect calorimetry |
| Change in short-chain fatty acids in the blood | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in waist and hip circumference in cm | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in lean body mass percentage measured by BodPod | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
| Change in red blood cells fatty acids | Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks. | Each participant will attend 3 sessions in total |
Countries
Canada
Outcome results
None listed