Clinical trial NCT04399460: The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Official title: The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Body Weight
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
First posted: 2020-05-22
Enrollment: 93
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in body weight
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Fecal Collection
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in blood glucose levels
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in fasting insulin (µIU/mL) levels in the blood
timeFrame: Change from baseline at 12 weeks
measure: Change in gut hormone levels measured in the blood
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in triacylglycerol level (mg/dL)
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in HbA1c (mmol/mol)
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in red blood cells fatty acids
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in resting metabolic rate
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in short-chain fatty acids in the blood
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in waist and hip circumference in cm
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
measure: Change in lean body mass percentage measured by BodPod
timeFrame: Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: