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Completed

NCT Number: NCT02581813

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

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.

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Key information

Conditions

Overweight Behavior Body Weight Children Inflammation Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I.D.E.A.L. for Adolescents Study - Higher Dairy

Behavioral

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

Behavioral

12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week

Primary outcomes

  1. Change in lean mass

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    body composition: lean mass (kg)

  2. Change in fat mass

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    body composition: fat mass (kg)

  3. Change in % body fat

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    body composition: % body fat

Secondary outcomes

  1. Change in TNF-α

    Time frame: 3 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)

  2. Change in IL-6 and IL-1β

    Time frame: 3 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)

  3. Change in Leptin

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    adipokine: leptin (mg/L)

  4. Change in Adiponectin

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    adipokine: adiponectin (mg/L)

  5. Change in lipids

    Time frame: 3 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)

  6. Change in glucose

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    cardiometabolic risk: glucose (mmol/L)

  7. Change in insulin

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    cardiometabolic risk: insulin (pmol/L)

  8. Change in 25OHD

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    hormone: 25-hydroxyvitamin D (25OHD nmol/L)

  9. Change in PTH

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    hormone: parathyroid hormone (PTH pmol/L)

  10. Changes in fitness

    Time frame: 3 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.

  11. Change in P1NP

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    bone turnover biomarker: P1NP (ug/L)

  12. Change in CTx

    Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)

    bone turnover biomarker: CTx (nmol/L)

Sponsors and collaborators

Lead sponsor

Brock University

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 21, 2015
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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