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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low-fat dairy products
Full-fat dairy products
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring low-fat dairy products, full-fat dairy products, weight loss and maintenance

Eligibility Criteria

8 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Laval UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Low-fat dairy products

Full-fat dairy products

Control

Arm Description

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

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

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)

Outcomes

Primary Outcome Measures

Dairy consumption
# of servings of dairy

Secondary Outcome Measures

Body weight (kg)
Body weight will be measured using standard laboratory methods
Systolic and diastolic blood pressure (mmHg)
Blood pressure will be measured using standard laboratory methods
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
Plasma lipids will be measured using standard laboratory methods
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
Oral microbiota (bacterial DNA from saliva)
Saliva samples will be collected.
Habitual food intake and diet quality
24-h web-based dietary recalls
Eating behaviours
Various validated questionnaires (e.g. Three-Factor Eating Questionnaire and Child Three-Factor Eating Questaionnaire) will be used to assess these traits
Physical activity
Physical activity diary
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.
Sleeping Habits
Pittsburgh Sleep Quality Index Questionnaire
Resting metabolic rate
Indirect calorimetry will be used
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.
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.
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.
Depression symptoms
All adult participants will complete the Beck Depression Inventory.
Anxiety symptoms
All adult participants will complete the State-Trait Anxiety Inventory.
Stress levels
All adult participants will complete the Perceived Stress Scale.

Full Information

First Posted
April 8, 2022
Last Updated
October 3, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT05417347
Brief Title
Full-fat Dairy Products, Body Weight Control and Metabolic Health
Official Title
he Role of Full-fat Dairy Products on Body Weight Control and Metabolic Health in Adults and Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
low-fat dairy products, full-fat dairy products, weight loss and maintenance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
This study will be single-blinded.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-fat dairy products
Arm Type
Active Comparator
Arm Description
Consumption of low-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)
Arm Title
Full-fat dairy products
Arm Type
Active Comparator
Arm Description
Consumption of high-fat dairy products (4 servings/day with 2 servings/day coming from yogurt)
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Low-fat dairy products
Intervention Description
Milk: low fat (less than 2% M.F.) Yogurt: less than 2% M.F. Cheese: less than 20% M.F.
Intervention Type
Other
Intervention Name(s)
Full-fat dairy products
Intervention Description
Milk: full-fat milk Yogurt: 2% and more M.F. Cheese: Regular cheese products
Primary Outcome Measure Information:
Title
Dairy consumption
Description
# of servings of dairy
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Body weight (kg)
Description
Body weight will be measured using standard laboratory methods
Time Frame
week 0, week 9, week 24
Title
Systolic and diastolic blood pressure (mmHg)
Description
Blood pressure will be measured using standard laboratory methods
Time Frame
week 0, week 9, week 24
Title
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
Description
Plasma lipids will be measured using standard laboratory methods
Time Frame
week 0, week 9, week 24
Title
Gastrointestinal peptides and hormones
Description
The following hormones will be measured: adiponectin, amylin, leptin, ghrelin, glucose insulinotropic peptide (GIP), glucagon-like peptide (GLP-1), peptide tyrosine tyrosine (PYY), cortisol
Time Frame
week 0, week 9, week 24
Title
Oral microbiota (bacterial DNA from saliva)
Description
Saliva samples will be collected.
Time Frame
week 0, week 9, week 24
Title
Habitual food intake and diet quality
Description
24-h web-based dietary recalls
Time Frame
week 0, week 9, week 24
Title
Eating behaviours
Description
Various validated questionnaires (e.g. Three-Factor Eating Questionnaire and Child Three-Factor Eating Questaionnaire) will be used to assess these traits
Time Frame
week 0, week 9, week 24
Title
Physical activity
Description
Physical activity diary
Time Frame
week 0, week 9, week 24
Title
Cravings
Description
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.
Time Frame
week 0, week 9, week 24
Title
Sleeping Habits
Description
Pittsburgh Sleep Quality Index Questionnaire
Time Frame
week 0, week 9, week 24
Title
Resting metabolic rate
Description
Indirect calorimetry will be used
Time Frame
week 0, week 9, week 24
Title
Binge Eating Tendencies
Description
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.
Time Frame
week 0, week 9, week 24
Title
Cognitive restraint, disinhibition, susceptibility to hunger
Description
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.
Time Frame
week 0, week 9, week 24
Title
Distress-related body esteem
Description
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.
Time Frame
week 0, week 9, week 24
Title
Depression symptoms
Description
All adult participants will complete the Beck Depression Inventory.
Time Frame
week 0, week 9, week 24
Title
Anxiety symptoms
Description
All adult participants will complete the State-Trait Anxiety Inventory.
Time Frame
week 0, week 9, week 24
Title
Stress levels
Description
All adult participants will complete the Perceived Stress Scale.
Time Frame
week 0, week 9, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Brunelle, MSc, RD
Phone
4186562131
Ext
406721
Email
lucie.brunelle@kin.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Shirin Panahi, PhD
Phone
4186562131
Ext
406721
Email
spanahi329@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicky Drapeau, PhD, RD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angelo Tremblay, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Brunelle, MSc, RD
Phone
4186562131
Ext
406721
Email
lucie.brunelle@kin.ulaval.ca

12. IPD Sharing Statement

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

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