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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; 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

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • St. Catharines, Ontario, Canada, L2S3A1
      • Brock University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RDa (Recommended dairy group); 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; 12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week
Experimental: LDa (Low dairy group); 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; 12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
No Intervention: GCon (growth controls); 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)

Collaborators and Investigators

• Sponsor: Brock University
• Collaborators: Dairy Farmers of Canada

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Body composition; inflammation; weight management; Bone health; nutrition intervention; Dairy foods
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: REB 14-284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO