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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02581813
Enrollment
61
Registered
2015-10-21
Start date
2016-05-31
Completion date
2019-05-31
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Obesity, Overweight

Keywords

Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management

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.

Interventions

BEHAVIORALI.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

BEHAVIORALI.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

Sponsors

Dairy Farmers of Canada
CollaboratorOTHER
Brock University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in lean mass3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)body composition: lean mass (kg)
Change in fat mass3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)body composition: fat mass (kg)
Change in % body fat3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)body composition: % body fat

Secondary

MeasureTime frameDescription
Change in Adiponectin3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)adipokine: adiponectin (mg/L)
Change in lipids3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)cardiometabolic risk: lipids (triglycerides, LDL, HDL, total cholesterol; mmol/L)
Change in glucose3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)cardiometabolic risk: glucose (mmol/L)
Change in insulin3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)cardiometabolic risk: insulin (pmol/L)
Change in TNF-α3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)inflammatory marker: tumor necrosis factor alpha (TNF-α; ng/L)
Change in PTH3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)hormone: parathyroid hormone (PTH pmol/L)
Changes in fitness3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)cardiovascular fitness and response to exercise (heart rate (HR; bpm) , oxygen consumption (VO2 max) using a progressive exercise test to exhaustion.
Change in P1NP3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)bone turnover biomarker: P1NP (ug/L)
Change in CTx3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)bone turnover biomarker: CTx (nmol/L)
Change in 25OHD3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)hormone: 25-hydroxyvitamin D (25OHD nmol/L)
Change in IL-6 and IL-1β3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1β; ng/L)
Change in Leptin3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)adipokine: leptin (mg/L)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026