ObesityNCT05417347
Full-fat Dairy Products, Body Weight Control and Metabolic Health
A study testing Low-fat dairy products and Full-fat dairy products in people with Obesity, run by Laval University at 1 site in Canada.
Trial summary
The aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. Read more about this study
- Who is it for?
- Ages 8 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low-fat dairy products and Full-fat dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2021to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parent criteria are as follows:
- men and women between 18-55 years
- body mass index (BMI) between 30-40 kg/m2
- absence of pregnancy, breastfeeding or menopause (no menstruation)
- stable body weight (weight change <5 kg for three months prior to screening).
- Family criteria are as follows:
Show all 9Show fewer
- being a family composed of at least one parent (mother/father) and at least two children between 8 to 16 years old (families between 3 to 5 persons). Families with at least one obese parent (BMI between 30-40 kg/m2) will be recruited since children coming from these families are more at risk of developing obesity and may benefit more from dairy products
- all participants should have no allergies to dairy products or lactose intolerance and be in good general health.
- since we are recruiting adults with obesity and dairy products may positively impact several metabolic markers, those with hypertension or deteriorated blood glucose and lipid profiles and/or taking medications will also be considered.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laval University
Québec, Quebec, G1V0A6
Lucie Brunelle, MSc, RD, 4186562131 ext. 406721, lucie.brunelle@kin.ulaval.ca
About this study
Official title: he Role of Full-fat Dairy Products on Body Weight Control and Metabolic Health in Adults and Children
The aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. The deleterious health consequences of obesity are recognized as a major financial burden to health care systems. Diets rich in fruits and vegetables and that also include dairy products have been suggested to play a role in the control of body weight and other aspects of health including the maintenance of healthy gut bacteria. In contrast, full-fat diets, especially those high in saturated fat, have been linked with negative health effects. Although dairy products represent an important source of saturated fat, it has been proposed that the combination of nutrients and complex food forms of the various dairy products may in fact counteract the negative effects of the fat. Thus, increased consumption of dairy products could very likely provide a partial dietary solution to improved body weight and metabolic health. Therefore, we are investigating the role of both full-fat and low-fat dairy products in their different physical forms (i.e. varying levels of fat that contribute to different textures) on appetite, food intake, control of blood sugar (glucose), body weight, cholesterol levels, and blood pressure in both children and adults. Existing dairy products (milk, cheese, and yogurt) ranging in fat content will be compared for their effects on satiety, food intake, glucose, insulin, satiety hormones, gut bacteria and other metabolic parameters linked to cardiometabolic health in normal weight children and adults, as well as in children and adults living with overweight and obesity.
Read the detailed description
The overall objective is to examine the long-term effects of full-fat dairy products on appetite and body weight control, diet quality, and metabolic health in adults living with obesity (18-55 y) and in children (8-16 y). This project also aims to identify some key mechanisms (i.e. gut peptides, gut microbiota) involved in the beneficial impact of dairy products on these outcomes. This study aims to evaluate the impact of a web-based nutrition intervention integrating full-fat or low-fat dairy products into the diets of families (at least one parent with BMI >30 kg/m2) under free-living conditions, on overall dairy consumption, body weight and composition, diet quality, eating and psychobehavioural traits and cardiometabolic outcomes, in normal weight/obese adults and children. This is a randomized, controlled, single-blind study consisting of three parallel groups. Families (n=25/group) will be randomized to either an intervention promoting either 1) low-fat or 2) full-fat dairy) or 3) control group (no intervention but same follow-up) over an 8-week period. The nutrition intervention aims to increase the quantity and variety of dairy products (i.e. low and full-fat milk, yogurt and cheese) in the diet. Evaluation periods for each family will be conducted before the study (week 0 in the lab), at the end (week 9 at home) and after 3 months (week 20 at home) after the intervention. Measurements include anthropometry, fasting lipid and glycemic profiles, diet quality, eating and psychobehavioral traits and food reward/appreciation/acceptance. The proposed research will provide timely data required to support recommendations to consume low and full-fat dairy products in individuals living with obesity, particularly during weight loss and maintenance. It will also provide the basis for family interventions that have the potential to positively impact diet quality and dairy consumption.
- Conditions
- Obesity
- Being tested
- Low-fat dairy products, Full-fat dairy products
- Keywords
- low-fat dairy products, full-fat dairy products, weight loss and maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dairy productsOther
Milk: low fat (less than 2% M.F.) Yogurt: less than 2% M.F. Cheese: less than 20% M.F.
Full-fat dairy productsOther
Milk: full-fat milk Yogurt: 2% and more M.F. Cheese: Regular cheese products
| Study group | Role | What they receive |
|---|---|---|
| Low-fat dairy products | Active comparator | Consumption of low-fat dairy products (4 servings/day with 2 servings/day coming from yogurt) Receives: Other: Low-fat dairy products |
| Full-fat dairy products | Active comparator | Consumption of high-fat dairy products (4 servings/day with 2 servings/day coming from yogurt) Receives: Other: Full-fat dairy products |
| Control | No intervention | Will be recommended to choose low-fat dairy products and alternatives based on recommendations from the 2007 Canadian Food Guide (2 servings/day for adults and 3-4 servings/day for children) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dairy consumption
# of servings of dairy
Measured: 8 weeks
Secondary outcomes (17)
Body weight (kg)
Body weight will be measured using standard laboratory methods
Measured: week 0, week 9, week 24
Systolic and diastolic blood pressure (mmHg)
Blood pressure will be measured using standard laboratory methods
Measured: week 0, week 9, week 24
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
Plasma lipids will be measured using standard laboratory methods
Measured: week 0, week 9, week 24
Gastrointestinal peptides and hormones
The following hormones will be measured: adiponectin, amylin, leptin, ghrelin, glucose insulinotropic peptide (GIP), glucagon-like peptide (GLP-1), peptide tyrosine tyrosine (PYY), cortisol
Measured: week 0, week 9, week 24
Oral microbiota (bacterial DNA from saliva)
Saliva samples will be collected.
Measured: week 0, week 9, week 24
Habitual food intake and diet quality
24-h web-based dietary recalls
Measured: week 0, week 9, week 24
Eating behaviours
Various validated questionnaires (e.g. Three-Factor Eating Questionnaire and Child Three-Factor Eating Questaionnaire) will be used to assess these traits
Measured: week 0, week 9, week 24
Physical activity
Physical activity diary
Measured: week 0, week 9, week 24
Cravings
All adult participants will complete the State/Trait Food Cravings Questionnaire to examine eating behaviour traits and factors which could influence appetite control and metabolic variables such as restraint behaviour and sleep deprivation. Each parent will complete the child's feeding questionnaire and the caregiver feeding style questionnaire to assess parental feeding practices.
Measured: week 0, week 9, week 24
Sleeping Habits
Pittsburgh Sleep Quality Index Questionnaire
Measured: week 0, week 9, week 24
Resting metabolic rate
Indirect calorimetry will be used
Measured: week 0, week 9, week 24
Binge Eating Tendencies
All adult participants will complete the Binge Scale to examine eating behaviour traits and factors which could influence appetite control and metabolic variables such as restraint behaviour and sleep deprivation. Each parent will complete the child's feeding questionnaire and the caregiver feeding style questionnaire to assess parental feeding practices.
Measured: week 0, week 9, week 24
Cognitive restraint, disinhibition, susceptibility to hunger
All adult participants will complete the Three Factor Eating Questionnaire to examine eating behaviour traits and factors which could influence appetite control and metabolic variables such as restraint behaviour and sleep deprivation. Each parent will complete the child's feeding questionnaire and the caregiver feeding style questionnaire to assess parental feeding practices.
Measured: week 0, week 9, week 24
Distress-related body esteem
All adult participants will complete the Body Esteem Scale to examine eating behaviour traits and factors which could influence appetite control and metabolic variables such as restraint behaviour and sleep deprivation. Each parent will complete the child's feeding questionnaire and the caregiver feeding style questionnaire to assess parental feeding practices.
Measured: week 0, week 9, week 24
Depression symptoms
All adult participants will complete the Beck Depression Inventory.
Measured: week 0, week 9, week 24
Anxiety symptoms
All adult participants will complete the State-Trait Anxiety Inventory.
Measured: week 0, week 9, week 24
Stress levels
All adult participants will complete the Perceived Stress Scale.
Measured: week 0, week 9, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start19 Jun 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (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 ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicky Drapeau, Laval University
- Investigators
- Vicky Drapeau, PhD, RD, Principal investigator, Laval UniversityAngelo Tremblay, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417347
- Sponsor's protocol ID
- DAIRY-2019-397
- Status last verified
- Oct 2023
- First submitted
- 8 Apr 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemay J, Provencher V, Tremblay A, Panahi S, Jacob R, Drapeau V. Effect of a web-based nutrition intervention among families to increase regular-fat and low-fat dairy products: a randomized controlled trial. Nutrition. 2026 Apr 21;152:113249. doi: 10.1016/j.nut.2026.113249. Online ahead of print.
PubMed 42669255
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Role of Full-fat Dairy Products on Body Weight Control and Metabolic Health in Adults and Children
- ClinicalTrials.gov ID
- NCT05417347
- Acronym / sponsor ID
- DAIRY-2019-397
- Conditions
- Obesity
- Keywords
- low-fat dairy products, full-fat dairy products, weight loss and maintenance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Jun 2022 (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 aim of this research is to clarify the role of different dairy products including both full-fat and low-fat dairy in maintaining health in adults and children through its effects beyond their well-known contribution of healthy nutrients. The deleterious health consequences of obesity are recognized as a major financial burden to health care systems. Diets rich in fruits and vegetables and that also include dairy products have been suggested to play a role in the control of body weight and other aspects of health including the maintenance of healthy gut bacteria. In contrast, full-fat diets, especially those high in saturated fat, have been linked with negative health effects. Although dairy products represent an important source of saturated fat, it has been proposed that the combination of nutrients and complex food forms of the various dairy products may in fact counteract the negative effects of the fat. Thus, increased consumption of dairy products could very likely provide a partial dietary solution to improved body weight and metabolic health. Therefore, we are investigating the role of both full-fat and low-fat dairy products in their different physical forms (i.e. varying levels of fat that contribute to different textures) on appetite, food intake, control of blood sugar (glucose), body weight, cholesterol levels, and blood pressure in both children and adults. Existing dairy products (milk, cheese, and yogurt) ranging in fat content will be compared for their effects on satiety, food intake, glucose, insulin, satiety hormones, gut bacteria and other metabolic parameters linked to cardiometabolic health in normal weight children and adults, as well as in children and adults living with overweight and obesity.
Detailed description
The overall objective is to examine the long-term effects of full-fat dairy products on appetite and body weight control, diet quality, and metabolic health in adults living with obesity (18-55 y) and in children (8-16 y). This project also aims to identify some key mechanisms (i.e. gut peptides, gut microbiota) involved in the beneficial impact of dairy products on these outcomes. This study aims to evaluate the impact of a web-based nutrition intervention integrating full-fat or low-fat dairy products into the diets of families (at least one parent with BMI >30 kg/m2) under free-living conditions, on overall dairy consumption, body weight and composition, diet quality, eating and psychobehavioural traits and cardiometabolic outcomes, in normal weight/obese adults and children. This is a randomized, controlled, single-blind study consisting of three parallel groups. Families (n=25/group) will be randomized to either an intervention promoting either 1) low-fat or 2) full-fat dairy) or 3) control group (no intervention but same follow-up) over an 8-week period. The nutrition intervention aims to increase the quantity and variety of dairy products (i.e. low and full-fat milk, yogurt and cheese) in the diet. Evaluation periods for each family will be conducted before the study (week 0 in the lab), at the end (week 9 at home) and after 3 months (week 20 at home) after the intervention. Measurements include anthropometry, fasting lipid and glycemic profiles, diet quality, eating and psychobehavioral traits and food reward/appreciation/acceptance. The proposed research will provide timely data required to support recommendations to consume low and full-fat dairy products in individuals living with obesity, particularly during weight loss and maintenance. It will also provide the basis for family interventions that have the potential to positively impact diet quality and dairy consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-fat dairy products | Active comparator | Other: Low-fat dairy productsConsumption of low-fat dairy products (4 servings/day with 2 servings/day coming from yogurt) |
| Full-fat dairy products | Active comparator | Other: Full-fat dairy productsConsumption of high-fat dairy products (4 servings/day with 2 servings/day coming from yogurt) |
| Control | No intervention | –Will be recommended to choose low-fat dairy products and alternatives based on recommendations from the 2007 Canadian Food Guide (2 servings/day for adults and 3-4 servings/day for children) |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- men and women between 18-55 years
- body mass index (BMI) between 30-40 kg/m2
- absence of pregnancy, breastfeeding or menopause (no menstruation)
- stable body weight (weight change <5 kg for three months prior to screening).
- being a family composed of at least one parent (mother/father) and at least two children between 8 to 16 years old (families between 3 to 5 persons). Families with at least one obese parent (BMI between 30-40 kg/m2) will be recruited since children coming from these families are more at risk of developing obesity and may benefit more from dairy products
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low-fat dairy productsMilk: low fat (less than 2% M.F.) Yogurt: less than 2% M.F. Cheese: less than 20% M.F. | Other | Low-fat dairy products |
| Full-fat dairy productsMilk: full-fat milk Yogurt: 2% and more M.F. Cheese: Regular cheese products | Other | Full-fat dairy products |
Primary outcome
Dairy consumption
Time frame: 8 weeks
# of servings of dairy
17 secondary outcomes
Body weight (kg)
Time frame: week 0, week 9, week 24
Systolic and diastolic blood pressure (mmHg)
Time frame: week 0, week 9, week 24
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
Time frame: week 0, week 9, week 24
Gastrointestinal peptides and hormones
Time frame: week 0, week 9, week 24
Oral microbiota (bacterial DNA from saliva)
Time frame: week 0, week 9, week 24
Habitual food intake and diet quality
Time frame: week 0, week 9, week 24
Eating behaviours
Time frame: week 0, week 9, week 24
Physical activity
Time frame: week 0, week 9, week 24
Cravings
Time frame: week 0, week 9, week 24
Sleeping Habits
Time frame: week 0, week 9, week 24
Resting metabolic rate
Time frame: week 0, week 9, week 24
Binge Eating Tendencies
Time frame: week 0, week 9, week 24
Cognitive restraint, disinhibition, susceptibility to hunger
Time frame: week 0, week 9, week 24
Distress-related body esteem
Time frame: week 0, week 9, week 24
Depression symptoms
Time frame: week 0, week 9, week 24
Anxiety symptoms
Time frame: week 0, week 9, week 24
Stress levels
Time frame: week 0, week 9, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 42669255Lemay J, Provencher V, Tremblay A, Panahi S, Jacob R, Drapeau V. Effect of a web-based nutrition intervention among families to increase regular-fat and low-fat dairy products: a randomized controlled trial. Nutrition. 2026 Apr 21;152:113249. doi: 10.1016/j.nut.2026.113249. Online ahead of print.
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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.
Vicky Drapeau, PhD, RD principal investigator
Laval University
Angelo Tremblay, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat dairy products and Full-fat dairy products in people with Obesity, run by Laval University at 1 site 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 0 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie Brunelle, MSc, RD (4186562131 ext. 406721, lucie.brunelle@kin.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dairy consumption (time frame: 8 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 NCT05417347, 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 5 Oct 2023.