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The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

Primary Purpose

Overweight or Obesity, Body Weight

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Dairy-based commercially available food products

Restrictive Eating

About this trial

This is an interventional treatment trial for Overweight or Obesity

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

BMI: ≥ 27 and ≤ 34.9 kg/m2
Fasting serum glucose: ≤ 7 mmol/L
Low ≤1 serving of dairy consumption
Waist circumference >88cm (women) and >102cm (men)
Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit.
Willing to abstain from alcohol consumption for 24 h prior to all test visits.
Willing to avoid vigorous physical activity for 24 h prior to all test visits.
Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator

Exclusion Criteria:

Fasting blood glucose > 7 mmol/L
Triglycerides ≥ 2.3 mmol/L
Smoking tobacco products and marijuana
Thyroid problems
Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
Presence of gastrointestinal disorder or surgeries within the past year.
Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.
Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months.
Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal
Unwillingness or inability to comply with the experimental procedures
Known intolerance, sensitivity or allergy to dairy products
Consumption of protein powders/protein supplements
Extreme dietary habits
Uncontrolled hypertension as defined by the average blood pressure measured at screening.
Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity
Excessive alcohol intake
Restrained Eaters

Sites / Locations

Mount Saint Vincent University
Department of Nutritional Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low Dairy Energy Restrictive Diet

3 Servings of Full-Fat Dairy with Energy Restrictive diet

3 Servings of Full-Fat Dairy but no energy restriction

Arm Description

Low-dairy (<1 serving/day) and 500kcal/deficit per day energy restrictive diet

Energy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Normal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Outcomes

Primary Outcome Measures

Change in body weight

Each participant will attend 8 sessions biweekly in total

Secondary Outcome Measures

Full Information

NCT ID

NCT04399460

First Posted

May 12, 2020

Last Updated

June 22, 2023

Sponsor

University of Toronto

Collaborators

Mount Saint Vincent University

1. Study Identification

Unique Protocol Identification Number

NCT04399460

Brief Title

The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

Official Title

The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

Mount Saint Vincent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.

Detailed Description

A total of 93 males and females will participate in the study at the University of Toronto. At the beginning and after 12 weeks, body weight, composition will be measured through Bodpod scans. Resting metabolic rate and thermogenesis will be measured by indirect calorimetry. Also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, HbA1c, short-chain fatty acid, red blood cells and FGF21. Urine samples will be collected throughout the study. A followup session at 16 weeks will reassess previous measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight or Obesity, Body Weight

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Dairy Energy Restrictive Diet

Arm Type

Experimental

Arm Description

Low-dairy (<1 serving/day) and 500kcal/deficit per day energy restrictive diet

Arm Title

3 Servings of Full-Fat Dairy with Energy Restrictive diet

Arm Type

Experimental

Arm Description

Energy-restrictive diet (500 kcal/deficit per day) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Arm Title

3 Servings of Full-Fat Dairy but no energy restriction

Arm Type

Experimental

Arm Description

Normal diet (no energy restriction) with 3 servings of full-fat dairy products from full-fat milk, and assorted yogurts and cheeses

Intervention Type

Other

Intervention Name(s)

Dairy-based commercially available food products

Intervention Description

Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses

Intervention Type

Other

Intervention Name(s)

Restrictive Eating

Intervention Description

Dietitian will assist with 500 kcal/day reduction through limiting of macronutrients 45-65% energy from carbohydrates 20-35% energy from fat 10-35% energy from protein

Primary Outcome Measure Information:

Title

Change in body weight

Description

Each participant will attend 8 sessions biweekly in total

Time Frame

Starting at the beginning of the study 0 week then biweekly for 7 sessions up to 12 weeks with a followed up at 16 weeks.

Other Pre-specified Outcome Measures:

Title

Fecal Collection

Description

Gut microbiome profiling

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in blood glucose levels

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in fasting insulin (µIU/mL) levels in the blood

Description

Each participant will attend 3 sessions in total

Time Frame

Change from baseline at 12 weeks

Title

Change in gut hormone levels measured in the blood

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in triacylglycerol level (mg/dL)

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in HbA1c (mmol/mol)

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in red blood cells fatty acids

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in resting metabolic rate

Description

Each participant will attend 3 sessions in total measured by Indirect calorimetry

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in short-chain fatty acids in the blood

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in waist and hip circumference in cm

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

Title

Change in lean body mass percentage measured by BodPod

Description

Each participant will attend 3 sessions in total

Time Frame

Starting at the beginning of the study 0 week then at 12 weeks with a followed up at 16 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI: ≥ 27 and ≤ 34.9 kg/m2 Fasting serum glucose: ≤ 7 mmol/L Low ≤1 serving of dairy consumption Waist circumference >88cm (women) and >102cm (men) Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit. Willing to abstain from alcohol consumption for 24 h prior to all test visits. Willing to avoid vigorous physical activity for 24 h prior to all test visits. Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator Exclusion Criteria: Fasting blood glucose > 7 mmol/L Triglycerides ≥ 2.3 mmol/L Smoking tobacco products and marijuana Thyroid problems Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease. Presence of gastrointestinal disorder or surgeries within the past year. Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement. Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months. Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal Unwillingness or inability to comply with the experimental procedures Known intolerance, sensitivity or allergy to dairy products Consumption of protein powders/protein supplements Extreme dietary habits Uncontrolled hypertension as defined by the average blood pressure measured at screening. Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity Excessive alcohol intake Restrained Eaters

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

G. Harvey Anderson, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Saint Vincent University

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3M 2J6

Country

Canada

Facility Name

Department of Nutritional Sciences

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 3E2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

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