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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581813
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : December 24, 2019
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
Andrea Josse, Brock University

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Children Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Weight Management Intervention With Increased Dairy Intake on Body Composition and Bone Health in Overweight and Obese Girls.
Study Start Date : May 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : May 2019

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581813


Locations
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Canada, Ontario
Brock University
St. Catharines, Ontario, Canada, L2S3A1
Sponsors and Collaborators
Brock University
Dairy Farmers of Canada
Investigators
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Principal Investigator: Andrea Josse, PhD Brock University
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Responsible Party: Andrea Josse, Assistant Professor, Department of Kinesiology, Brock University
ClinicalTrials.gov Identifier: NCT02581813    
Other Study ID Numbers: REB 14-284
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrea Josse, Brock University:
Bone health
Body composition
Dairy foods
Exercise
inflammation
nutrition intervention
weight management
Additional relevant MeSH terms:
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Overweight
Body Weight