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Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program?

NCT ID: NCT02581813

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study is to examine whether increased dairy intake, at the level recommended by Canada's Food Guide, combined with healthy eating and exercise, will improve body composition and bone turnover over 12 weeks in overweight and obese girls.

Detailed Description

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Three groups will participate in this study. Participants must be low dairy consumers (0-1 svgs/d) and do little to no structured physical activity at study entry. Each participant will be assigned to a group; one of two experimental groups or a control group. The two intervention groups will differ only in the amount of dairy consumed (4 svgs vs. 0-1 svg/d). Both will undergo the same exercise program (3x/wk) and will be counseled on healthy eating by a trained nutritionist-dietitian every month. The control group will be tested at the beginning and end of the study to help account for any growth-related changes during the study but will not receive any formal intervention. In each group, the investigators will assess body composition (muscle mass, fat mass, % body fat and regional fat mass) and bone (bone turnover markers). The investigators will also measure various metabolic and inflammatory markers, hormones as well as dietary intake, strength and fitness.

This study will determine whether increased intake of dairy products improve bone and body composition during a 12-week weight management intervention. The investigators expect the two groups participating in the intervention to show significant changes in body weight and body composition and greater gains in fitness compared to the control group. The investigators expect those consuming dairy to show greater improvements in body composition and bone health compared to those not consuming added dairy. The investigators also anticipate better vitamin D status and less whole-body inflammation in those consuming dairy. Both intervention groups should show improvements in fasting insulin, glucose and cholesterol.

Conditions

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Overweight Obesity Children

Keywords

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Bone health Body composition Dairy foods Exercise inflammation nutrition intervention weight management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RDa (Recommended dairy group)

4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise).

Group Type EXPERIMENTAL

I.D.E.A.L. for Adolescents Study - Higher Dairy

Intervention Type BEHAVIORAL

12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week

LDa (Low dairy group)

0-1 serving of dairy per day + exercise (the same as the RDa group)

Group Type EXPERIMENTAL

I.D.E.A.L. for Adolescents Study - Lower Dairy

Intervention Type BEHAVIORAL

12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week

GCon (growth controls)

This no-intervention group will serve as the control to account for growth during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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I.D.E.A.L. for Adolescents Study - Higher Dairy

12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week

Intervention Type BEHAVIORAL

I.D.E.A.L. for Adolescents Study - Lower Dairy

12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* at or above the age appropriate cut-offs for overweight (OW) or obese (OB) on WHO growth charts: ≥85-97% for OW and \>97% for OB for BMI
* between 10 and 18 years old
* menarcheal
* low dairy consumers (0-2 svgs/d and \<700 mg Ca/d measured by baseline FFQ)
* otherwise healthy (i.e. no diagnosed disease or illness)
* lower levels of physical activity (0-2 times/week)
* no allergy to dairy foods or diagnosed lactose intolerance
* not on medications related to a chronic condition or that affect bone health
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Farmers of Canada

OTHER

Sponsor Role collaborator

Brock University

OTHER

Sponsor Role lead

Responsible Party

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Andrea Josse

Assistant Professor, Department of Kinesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Josse, PhD

Role: PRINCIPAL_INVESTIGATOR

Brock University

Locations

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Brock University

St. Catharines, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB 14-284

Identifier Type: -

Identifier Source: org_study_id