Full-fat Dairy Products, Body Weight Control and Metabolic Health

Sponsor
Laval University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05417347
Collaborator
(none)
300
1
3
23.4
12.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Low-fat dairy products
  • Other: Full-fat dairy products
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Masking Description:
This study will be single-blinded.
Primary Purpose:
Prevention
Official Title:
he Role of Full-fat Dairy Products on Body Weight Control and Metabolic Health in Adults and Children
Actual Study Start Date :
Jun 19, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low-fat dairy products

Consumption of low-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)

Other: Low-fat dairy products
Milk: low fat (less than 2% M.F.) Yogurt: less than 2% M.F. Cheese: less than 20% M.F.

Active Comparator: Full-fat dairy products

Consumption of high-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)

Other: Full-fat dairy products
Milk: full-fat milk Yogurt: 2% and more M.F. Cheese: Regular cheese products

No Intervention: Control

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)

Outcome Measures

Primary Outcome Measures

  1. Dairy consumption [8 weeks]

    # of servings of dairy

Secondary Outcome Measures

  1. Body weight (kg) [week 0, week 9, week 24]

    Body weight will be measured using standard laboratory methods

  2. Systolic and diastolic blood pressure (mmHg) [week 0, week 9, week 24]

    Blood pressure will be measured using standard laboratory methods

  3. Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides) [week 0, week 9, week 24]

    Plasma lipids will be measured using standard laboratory methods

  4. Gastrointestinal peptides and hormones [week 0, week 9, week 24]

    The following hormones will be measured: adiponectin, amylin, leptin, ghrelin, glucose insulinotropic peptide (GIP), glucagon-like peptide (GLP-1), peptide tyrosine tyrosine (PYY), cortisol

  5. Oral microbiota (bacterial DNA from saliva) [week 0, week 9, week 24]

    Saliva samples will be collected.

  6. Habitual food intake and diet quality [week 0, week 9, week 24]

    24-h web-based dietary recalls

  7. Eating behaviours [week 0, week 9, week 24]

    Various validated questionnaires (e.g. Three-Factor Eating Questionnaire and Child Three-Factor Eating Questaionnaire) will be used to assess these traits

  8. Physical activity [week 0, week 9, week 24]

    Physical activity diary

  9. Cravings [week 0, week 9, week 24]

    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.

  10. Sleeping Habits [week 0, week 9, week 24]

    Pittsburgh Sleep Quality Index Questionnaire

  11. Resting metabolic rate [week 0, week 9, week 24]

    Indirect calorimetry will be used

  12. Binge Eating Tendencies [week 0, week 9, week 24]

    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.

  13. Cognitive restraint, disinhibition, susceptibility to hunger [week 0, week 9, week 24]

    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.

  14. Distress-related body esteem [week 0, week 9, week 24]

    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.

  15. Depression symptoms [week 0, week 9, week 24]

    All adult participants will complete the Beck Depression Inventory.

  16. Anxiety symptoms [week 0, week 9, week 24]

    All adult participants will complete the State-Trait Anxiety Inventory.

  17. Stress levels [week 0, week 9, week 24]

    All adult participants will complete the Perceived Stress Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laval University Quebec City Quebec Canada G1V0A6

Sponsors and Collaborators

  • Laval University

Investigators

  • Principal Investigator: Vicky Drapeau, PhD, RD, Laval University
  • Principal Investigator: Angelo Tremblay, PhD, Laval University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vicky Drapeau, Professor, Laval University
ClinicalTrials.gov Identifier:
NCT05417347
Other Study ID Numbers:
  • DAIRY-2019-397
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vicky Drapeau, Professor, Laval University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022