Full-fat Dairy Products, Body Weight Control and Metabolic Health
he Role of Full-fat Dairy Products on Body Weight Control and Metabolic Health in Adults and Children
1 other identifier
interventional
300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 2021
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2021
CompletedFirst Submitted
Initial submission to the registry
April 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedOctober 5, 2023
October 1, 2023
3.1 years
April 8, 2022
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dairy consumption
\# of servings of dairy
8 weeks
Secondary Outcomes (17)
Body weight (kg)
week 0, week 9, week 24
Systolic and diastolic blood pressure (mmHg)
week 0, week 9, week 24
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
week 0, week 9, week 24
Gastrointestinal peptides and hormones
week 0, week 9, week 24
Oral microbiota (bacterial DNA from saliva)
week 0, week 9, week 24
- +12 more secondary outcomes
Study Arms (3)
Low-fat dairy products
ACTIVE COMPARATORConsumption of low-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)
Full-fat dairy products
ACTIVE COMPARATORConsumption of high-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)
Control
NO INTERVENTIONWill 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)
Interventions
Milk: low fat (less than 2% M.F.) Yogurt: less than 2% M.F. Cheese: less than 20% M.F.
Milk: full-fat milk Yogurt: 2% and more M.F. Cheese: Regular cheese products
Eligibility Criteria
You may qualify if:
- 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
Study Sites (1)
Laval University
Québec, Quebec, G1V0A6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vicky Drapeau, PhD, RD
Laval University
- PRINCIPAL INVESTIGATOR
Angelo Tremblay, PhD
Laval University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- This study will be single-blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2022
First Posted
June 14, 2022
Study Start
June 19, 2021
Primary Completion
August 1, 2024
Study Completion
August 1, 2024
Last Updated
October 5, 2023
Record last verified: 2023-10