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

October 3, 2023 updated by: Vicky Drapeau, Laval University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1V0A6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 51 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dairy consumption
Time Frame: 8 weeks
# of servings of dairy
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight (kg)
Time Frame: week 0, week 9, week 24
Body weight will be measured using standard laboratory methods
week 0, week 9, week 24
Systolic and diastolic blood pressure (mmHg)
Time Frame: week 0, week 9, week 24
Blood pressure will be measured using standard laboratory methods
week 0, week 9, week 24
Plasma lipids (total cholesterol, HDL and LDL cholesterol, triglycerides)
Time Frame: week 0, week 9, week 24
Plasma lipids will be measured using standard laboratory methods
week 0, week 9, week 24
Gastrointestinal peptides and hormones
Time Frame: 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
week 0, week 9, week 24
Oral microbiota (bacterial DNA from saliva)
Time Frame: week 0, week 9, week 24
Saliva samples will be collected.
week 0, week 9, week 24
Habitual food intake and diet quality
Time Frame: week 0, week 9, week 24
24-h web-based dietary recalls
week 0, week 9, week 24
Eating behaviours
Time Frame: 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
week 0, week 9, week 24
Physical activity
Time Frame: week 0, week 9, week 24
Physical activity diary
week 0, week 9, week 24
Cravings
Time Frame: 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.
week 0, week 9, week 24
Sleeping Habits
Time Frame: week 0, week 9, week 24
Pittsburgh Sleep Quality Index Questionnaire
week 0, week 9, week 24
Resting metabolic rate
Time Frame: week 0, week 9, week 24
Indirect calorimetry will be used
week 0, week 9, week 24
Binge Eating Tendencies
Time Frame: 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.
week 0, week 9, week 24
Cognitive restraint, disinhibition, susceptibility to hunger
Time Frame: 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.
week 0, week 9, week 24
Distress-related body esteem
Time Frame: 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.
week 0, week 9, week 24
Depression symptoms
Time Frame: week 0, week 9, week 24
All adult participants will complete the Beck Depression Inventory.
week 0, week 9, week 24
Anxiety symptoms
Time Frame: week 0, week 9, week 24
All adult participants will complete the State-Trait Anxiety Inventory.
week 0, week 9, week 24
Stress levels
Time Frame: week 0, week 9, week 24
All adult participants will complete the Perceived Stress Scale.
week 0, week 9, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vicky Drapeau, PhD, RD, Laval University
  • Principal Investigator: Angelo Tremblay, PhD, Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAIRY-2019-397

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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