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

NCT04399460 | Active Not Recruiting

• 1 other identifier: DFC_LTDairy_2019
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Overweight or Obesity; Body Weight

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Each participant will attend 8 sessions biweekly in total

  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.

Other Outcomes (11)

• Fecal Collection

  Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

• Change in blood glucose levels

  Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

• Change in fasting insulin (µIU/mL) levels in the blood

  Change from baseline at 12 weeks

Study Arms (3)

Low Dairy Energy Restrictive Diet

EXPERIMENTAL

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

Other: Restrictive Eating

3 Servings of Full-Fat Dairy with Energy Restrictive diet

EXPERIMENTAL

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

Other: Dairy-based commercially available food products; Other: Restrictive Eating

3 Servings of Full-Fat Dairy but no energy restriction

EXPERIMENTAL

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

Other: Dairy-based commercially available food products

Interventions

Dairy-based commercially available food products OTHER

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

3 Servings of Full-Fat Dairy but no energy restriction; 3 Servings of Full-Fat Dairy with Energy Restrictive diet

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

3 Servings of Full-Fat Dairy with Energy Restrictive diet; Low Dairy Energy Restrictive Diet

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Mount Saint Vincent University: collaborator

Study Sites (2)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

• Anderson GH, Chen Zhou CZ, Vien S, Soo M, Salamat S, Akbarifakhrabadi M, Chomka L, Kathirvel P, Siddiqi F, Fabek H, Luhovyy B. The effect of three daily servings of full-fat dairy for 12 weeks on body weight, body composition, energy metabolism, blood lipids, and dietary intake of adults with overweight and obesity. J Nutr. 2026 Jan 22:101373. doi: 10.1016/j.tjnut.2026.101373. Online ahead of print.

  PMID: 41580085 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• G. Harvey Anderson, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 22, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)