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NCT Number: NCT04399460

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Saint Vincent University, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dairy-based commercially available food products

Other

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

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

Primary outcomes

  1. Change in body weight

    Time frame: 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.

    Each participant will attend 8 sessions biweekly in total

Other outcomes

  1. Fecal Collection

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

    Gut microbiome profiling

  2. Change in blood glucose levels

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

    Each participant will attend 3 sessions in total

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

    Time frame: Change from baseline at 12 weeks

    Each participant will attend 3 sessions in total

  4. Change in gut hormone levels measured in the blood

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

    Each participant will attend 3 sessions in total

  5. Change in triacylglycerol level (mg/dL)

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

    Each participant will attend 3 sessions in total

  6. Change in HbA1c (mmol/mol)

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

    Each participant will attend 3 sessions in total

  7. Change in red blood cells fatty acids

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

    Each participant will attend 3 sessions in total

  8. Change in resting metabolic rate

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

    Each participant will attend 3 sessions in total measured by Indirect calorimetry

  9. Change in short-chain fatty acids in the blood

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

    Each participant will attend 3 sessions in total

  10. Change in waist and hip circumference in cm

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

    Each participant will attend 3 sessions in total

  11. Change in lean body mass percentage measured by BodPod

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

    Each participant will attend 3 sessions in total

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Mount Saint Vincent University

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
May 22, 2020
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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