The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

NCT ID: NCT04399460

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-12-30

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.

Conditions

Overweight or Obesity; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Dairy Energy Restrictive Diet

Low-dairy (\<1 serving/day) and 500kcal/deficit per day energy restrictive diet

Group Type: EXPERIMENTAL

Restrictive Eating

Intervention Type: 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

3 Servings of Full-Fat Dairy with Energy Restrictive diet

Energy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Group Type: EXPERIMENTAL

Dairy-based commercially available food products

Intervention Type: OTHER

Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses

Restrictive Eating

Intervention Type: 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

3 Servings of Full-Fat Dairy but no energy restriction

Normal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Group Type: EXPERIMENTAL

Dairy-based commercially available food products

Intervention Type: OTHER

Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses

Interventions

Dairy-based commercially available food products

Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses

Intervention Type: OTHER

Restrictive 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Saint Vincent University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

G. Harvey Anderson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

G. Harvey Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Mount Saint Vincent University

Halifax, Nova Scotia, Canada

Department of Nutritional Sciences

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

DFC_LTDairy_2019

Identifier Type: -

Identifier Source: org_study_id