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

Study Overview
=================
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.

Official Title
-----------------
Effects of a Weight Management Intervention With Increased Dairy Intake on Body Composition and Bone Health in Overweight and Obese Girls.

Conditions
-----------------
Overweight, Obesity, Children

Intervention / Treatment
-----------------
* Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy
* Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDa (Recommended dairy group)<br>4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise). | Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy<br>* 12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week<br>|
| Experimental: LDa (Low dairy group)<br>0-1 serving of dairy per day + exercise (the same as the RDa group) | Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy<br>* 12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week<br>|
| No Intervention: GCon (growth controls)<br>This no-intervention group will serve as the control to account for growth during the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean mass | body composition: lean mass (kg) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in fat mass | body composition: fat mass (kg) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in % body fat | body composition: % body fat | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TNF-α | inflammatory marker: tumor necrosis factor alpha (TNF-α; ng/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in IL-6 and IL-1β | inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1β; ng/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in Leptin | adipokine: leptin (mg/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in Adiponectin | adipokine: adiponectin (mg/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in lipids | cardiometabolic risk: lipids (triglycerides, LDL, HDL, total cholesterol; mmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in glucose | cardiometabolic risk: glucose (mmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in insulin | cardiometabolic risk: insulin (pmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in 25OHD | hormone: 25-hydroxyvitamin D (25OHD nmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in PTH | hormone: parathyroid hormone (PTH pmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Changes in fitness | cardiovascular fitness and response to exercise (heart rate (HR; bpm) , oxygen consumption (VO2 max) using a progressive exercise test to exhaustion. | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in P1NP | bone turnover biomarker: P1NP (ug/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 
| Change in CTx | bone turnover biomarker: CTx (nmol/L) | 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management