Clinical trial
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04399460
Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age30 Years to 50 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight or Obesity, Body Weight
Full registry criteria
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
Treatments and study arms
Dairy-based commercially available food products
Other
Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
Restrictive Eating
Other
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
Primary outcomes
Change in body weightStarting 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