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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581813
• Other study ID #: REB 14-284
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2019

Study information

• Verified date: December 2019
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Obesity
• Overweight

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Brock University	St. Catharines	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Change in TNF-a	inflammatory marker: tumor necrosis factor alpha (TNF-a; ng/L)	3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary	Change in IL-6 and IL-1ß	inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1ß; ng/L)	3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary	Change in Leptin	adipokine: leptin (mg/L)	3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary	Change in Adiponectin	adipokine: adiponectin (mg/L)	3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)