NCT04399460Active, not recruiting
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 93 (estimated)
- First submitted
- 12 May 2020
- Start date
- 1 Sept 2020
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- University of Toronto
- Diseases
- Obesity
- NCT number
- NCT04399460
What you commit to
- Study type: Interventional
- Planned participants: 93
- From 1 Sept 2020 to the primary completion date, 30 Sept 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity
Other illness
- Presence of gastrointestinal disorder or surgeries within the past year.
- Known intolerance, sensitivity or allergy to dairy products
- Uncontrolled hypertension as defined by the average blood pressure measured at screening.
Lab values
- Fasting blood glucose \> 7 mmol/L
- Triglycerides ≥ 2.3 mmol/L
- 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.
Other
- Smoking tobacco products and marijuana
- Thyroid problems
- 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
- Consumption of protein powders/protein supplements
- Extreme dietary habits
- Excessive alcohol intake
- Restrained Eaters
Who the study is looking for
- 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
Age in the registry: 30 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Saint Vincent University Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Department of Nutritional Sciences Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.