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

Primary Purpose

Overweight, Obesity, Children

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
I.D.E.A.L. for Adolescents Study - Higher Dairy
I.D.E.A.L. for Adolescents Study - Lower Dairy
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management

Eligibility Criteria

10 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Participants will be excluded from participation in the study if they do not meet one or more of the above inclusion criteria.

Sites / Locations

  • Brock University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

RDa (Recommended dairy group)

LDa (Low dairy group)

GCon (growth controls)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in lean mass
body composition: lean mass (kg)
Change in fat mass
body composition: fat mass (kg)
Change in % body fat
body composition: % body fat

Secondary Outcome Measures

Change in TNF-α
inflammatory marker: tumor necrosis factor alpha (TNF-α; ng/L)
Change in IL-6 and IL-1β
inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1β; ng/L)
Change in Leptin
adipokine: leptin (mg/L)
Change in Adiponectin
adipokine: adiponectin (mg/L)
Change in lipids
cardiometabolic risk: lipids (triglycerides, LDL, HDL, total cholesterol; mmol/L)
Change in glucose
cardiometabolic risk: glucose (mmol/L)
Change in insulin
cardiometabolic risk: insulin (pmol/L)
Change in 25OHD
hormone: 25-hydroxyvitamin D (25OHD nmol/L)
Change in PTH
hormone: parathyroid hormone (PTH pmol/L)
Changes in fitness
cardiovascular fitness and response to exercise (heart rate (HR; bpm) , oxygen consumption (VO2 max) using a progressive exercise test to exhaustion.
Change in P1NP
bone turnover biomarker: P1NP (ug/L)
Change in CTx
bone turnover biomarker: CTx (nmol/L)

Full Information

First Posted
October 13, 2015
Last Updated
December 20, 2019
Sponsor
Brock University
Collaborators
Dairy Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02581813
Brief Title
Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program?
Official Title
Effects of a Weight Management Intervention With Increased Dairy Intake on Body Composition and Bone Health in Overweight and Obese Girls.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University
Collaborators
Dairy Farmers of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Children
Keywords
Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RDa (Recommended dairy group)
Arm Type
Experimental
Arm Description
4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise).
Arm Title
LDa (Low dairy group)
Arm Type
Experimental
Arm Description
0-1 serving of dairy per day + exercise (the same as the RDa group)
Arm Title
GCon (growth controls)
Arm Type
No Intervention
Arm Description
This no-intervention group will serve as the control to account for growth during the study.
Intervention Type
Behavioral
Intervention Name(s)
I.D.E.A.L. for Adolescents Study - Higher Dairy
Intervention Description
12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week
Intervention Type
Behavioral
Intervention Name(s)
I.D.E.A.L. for Adolescents Study - Lower Dairy
Intervention Description
12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
Primary Outcome Measure Information:
Title
Change in lean mass
Description
body composition: lean mass (kg)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in fat mass
Description
body composition: fat mass (kg)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in % body fat
Description
body composition: % body fat
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary Outcome Measure Information:
Title
Change in TNF-α
Description
inflammatory marker: tumor necrosis factor alpha (TNF-α; ng/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in IL-6 and IL-1β
Description
inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1β; ng/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in Leptin
Description
adipokine: leptin (mg/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in Adiponectin
Description
adipokine: adiponectin (mg/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in lipids
Description
cardiometabolic risk: lipids (triglycerides, LDL, HDL, total cholesterol; mmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in glucose
Description
cardiometabolic risk: glucose (mmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in insulin
Description
cardiometabolic risk: insulin (pmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in 25OHD
Description
hormone: 25-hydroxyvitamin D (25OHD nmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in PTH
Description
hormone: parathyroid hormone (PTH pmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Changes in fitness
Description
cardiovascular fitness and response to exercise (heart rate (HR; bpm) , oxygen consumption (VO2 max) using a progressive exercise test to exhaustion.
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in P1NP
Description
bone turnover biomarker: P1NP (ug/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Title
Change in CTx
Description
bone turnover biomarker: CTx (nmol/L)
Time Frame
3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Participants will be excluded from participation in the study if they do not meet one or more of the above inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Josse, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S3A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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