Overweight or ObesityNCT04399460
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
A study testing Dairy-based commercially available food products and Restrictive Eating in people with Overweight or Obesity and Body Weight, run by University of Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity, Body Weight
- What is being tested?
- Dairy-based commercially available food products and Restrictive Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2020to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Saint Vincent University
Halifax, Nova Scotia, B3M 2J6
Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
About this study
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.
Read the 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
- Being tested
- Dairy-based commercially available food products, Restrictive Eating
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy-based commercially available food productsOther
Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
Restrictive EatingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Low Dairy Energy Restrictive Diet | Experimental | Low-dairy (<1 serving/day) and 500kcal/deficit per day energy restrictive diet Receives: 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 Receives: 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 Receives: Other: Dairy-based commercially available food products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Each participant will attend 8 sessions biweekly in total
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Sep 2020
- Primary completion30 Sep 2023
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Saint Vincent University
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399460
- Sponsor's protocol ID
- DFC_LTDairy_2019
- Status last verified
- Mar 2025
- First submitted
- 12 May 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Apr;156(4):101373. doi: 10.1016/j.tjnut.2026.101373. Epub 2026 Jan 22.
PubMed 41580085
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control
- ClinicalTrials.gov ID
- NCT04399460
- Acronym / sponsor ID
- DFC_LTDairy_2019
- Conditions
- Overweight or Obesity, Body Weight
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mount Saint Vincent University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dairy Energy Restrictive Diet | Experimental | Other: Restrictive EatingLow-dairy (<1 serving/day) and 500kcal/deficit per day energy restrictive diet |
| 3 Servings of Full-Fat Dairy with Energy Restrictive diet | Experimental | Other: Dairy-based commercially available food products, Other: Restrictive EatingEnergy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses |
| 3 Servings of Full-Fat Dairy but no energy restriction | Experimental | Other: Dairy-based commercially available food productsNormal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy-based commercially available food productsFull-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses | Other | 3 Servings of Full-Fat Dairy but no energy restriction, 3 Servings of Full-Fat Dairy with Energy Restrictive diet |
| Restrictive EatingDietitian 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 | Other | 3 Servings of Full-Fat Dairy with Energy Restrictive diet, Low Dairy Energy Restrictive Diet |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41580085Anderson 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 Apr;156(4):101373. doi: 10.1016/j.tjnut.2026.101373. Epub 2026 Jan 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Harvey Anderson, PhD principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy-based commercially available food products and Restrictive Eating in people with Overweight or Obesity and Body Weight, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.