Status:
ACTIVE_NOT_RECRUITING
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Mount Saint Vincent University
Conditions:
Overweight or Obesity
Body Weight
Eligibility:
All Genders
30-50 years
Phase:
NA
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 heal...
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. Restin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04399460
Start Date
September 1 2020
End Date
December 30 2025
Last Update
March 28 2025
Active Locations (2)
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1
Mount Saint Vincent University
Halifax, Nova Scotia, Canada, B3M 2J6
2
Department of Nutritional Sciences
Toronto, Ontario, Canada, M5S 3E2