Clinical trial NCT02581813: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Children
Keywords: Bone health
Body composition
Dairy foods
Exercise
inflammation
nutrition intervention
weight management
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Dairy Farmers of Canada
First posted: 2015-10-21
Enrollment: 61
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in lean mass
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in fat mass
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in % body fat
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary outcomes:
measure: Change in TNF-α
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in IL-6 and IL-1β
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in Leptin
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in Adiponectin
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in lipids
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in glucose
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in insulin
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in 25OHD
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in PTH
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Changes in fitness
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in P1NP
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
measure: Change in CTx
timeFrame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Other outcomes:
Locations:
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Andrea Josse, PhD
role: PRINCIPAL_INVESTIGATOR
References: