OverweightNCT02581813
Does Dairy Benefit Bone & Body Composition in Overweight Girls Undergoing a Weight Management Program?
A study testing I.D.E.A.L. for Adolescents Study - Higher Dairy and I.D.E.A.L. for Adolescents Study - Lower Dairy in people with Overweight and Obesity, run by Brock University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Children
- What is being tested?
- I.D.E.A.L. for Adolescents Study - Higher Dairy and I.D.E.A.L. for Adolescents Study - Lower Dairy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Weight Management Intervention With Increased Dairy Intake on Body Composition and Bone Health in Overweight and Obese Girls.
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.
Read the 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.
- Conditions
- Overweight, Obesity, Children
- Being tested
- I.D.E.A.L. for Adolescents Study - Higher Dairy, I.D.E.A.L. for Adolescents Study - Lower Dairy
- Keywords
- Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management
- Medical subject headings
- Overweight, Obesity, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I.D.E.A.L. for Adolescents Study - Higher DairyBehavioural
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 DairyBehavioural
12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| RDa (Recommended dairy group) | Experimental | 4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise). Receives: Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy |
| LDa (Low dairy group) | Experimental | 0-1 serving of dairy per day + exercise (the same as the RDa group) Receives: Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy |
| GCon (growth controls) | No intervention | This no-intervention group will serve as the control to account for growth during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean mass
body composition: lean mass (kg)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in fat mass
body composition: fat mass (kg)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in % body fat
body composition: % body fat
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Secondary outcomes (12)
Change in TNF-α
inflammatory marker: tumor necrosis factor alpha (TNF-α; ng/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in IL-6 and IL-1β
inflammatory markers: Interleukin 6 (IL-6; ng/L), interleukin 1 beta (IL-1β; ng/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in Leptin
adipokine: leptin (mg/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in Adiponectin
adipokine: adiponectin (mg/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in lipids
cardiometabolic risk: lipids (triglycerides, LDL, HDL, total cholesterol; mmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in glucose
cardiometabolic risk: glucose (mmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in insulin
cardiometabolic risk: insulin (pmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in 25OHD
hormone: 25-hydroxyvitamin D (25OHD nmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in PTH
hormone: parathyroid hormone (PTH pmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Changes in fitness
cardiovascular fitness and response to exercise (heart rate (HR; bpm) , oxygen consumption (VO2 max) using a progressive exercise test to exhaustion.
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in P1NP
bone turnover biomarker: P1NP (ug/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in CTx
bone turnover biomarker: CTx (nmol/L)
Measured: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionOct 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, Andrea Josse, Brock University
- Investigators
- Andrea Josse, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581813
- Sponsor's protocol ID
- REB 14-284
- Status last verified
- Dec 2019
- First submitted
- 13 Oct 2015
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Management Intervention With Increased Dairy Intake on Body Composition and Bone Health in Overweight and Obese Girls.
- ClinicalTrials.gov ID
- NCT02581813
- Acronym / sponsor ID
- REB 14-284
- Conditions
- Overweight, Obesity, Children
- Keywords
- Bone health, Body composition, Dairy foods, Exercise, inflammation, nutrition intervention, weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- May 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RDa (Recommended dairy group) | Experimental | Behavioral: I.D.E.A.L. for Adolescents Study - Higher Dairy4 servings of dairy per day + exercise (3 times per week with combination of aerobic and resistance exercise). |
| LDa (Low dairy group) | Experimental | Behavioral: I.D.E.A.L. for Adolescents Study - Lower Dairy0-1 serving of dairy per day + exercise (the same as the RDa group) |
| GCon (growth controls) | No intervention | –This no-intervention group will serve as the control to account for growth during the study. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I.D.E.A.L. for Adolescents Study - Higher Dairy12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week | Behavioural | RDa (Recommended dairy group) |
| I.D.E.A.L. for Adolescents Study - Lower Dairy12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week | Behavioural | LDa (Low dairy group) |
Primary outcome
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)
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)
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
12 secondary outcomes
Change in TNF-α
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
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)
Change in Leptin
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in Adiponectin
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in lipids
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in glucose
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in insulin
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in 25OHD
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in PTH
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Changes in fitness
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in P1NP
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Change in CTx
Time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Josse, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I.D.E.A.L. for Adolescents Study - Higher Dairy and I.D.E.A.L. for Adolescents Study - Lower Dairy in people with Overweight and Obesity, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean mass (time frame: 3 times during the study (week 0 pre-intervention; week 12 post-intervention; week 24 follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.