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DAWL (Dairy and Weight Loss) Study

This study has been withdrawn prior to enrollment.
(Grant not funded, study will not launch)
Sponsor:
Collaborators:
Purdue University
University of Saskatchewan
Information provided by:
University of Guelph
ClinicalTrials.gov Identifier:
NCT01337895
First received: April 15, 2011
Last updated: November 10, 2011
Last verified: August 2011
History of Changes
  Purpose
  • Objectives Taking a 'whole foods' approach, we will investigate (i) whether consumption of isocaloric diets containing ≥4 vs. ≤1 servings of dairy products per day for 16 weeks results in greater body fat loss in energy-restricted overweight/obese premenopausal women; (ii) the role of dairy product consumption in influencing physiological and metabolic factors which may precede or accompany changes in body composition, including in enzymes which synthesize and break down body fat; and (iii) factors, including obesity phenotype, which may influence the response of body composition to dairy product consumption.
  • Background

With the obesity epidemic showing no signs of abating, there is ongoing interest, both at the lay public and scientific levels, in manipulating the diet to promote weight, specifically fat, loss. One such promising manipulation is an increase in, or perhaps more precisely, an isocaloric substitution of, dairy product consumption. The inverse association between Body Mass Index (BMI) and dietary calcium - for which dairy products are the main source - was first described in 1984 and has since been supported by various levels of evidence, but not consistently. Heaney recently described this literature as "confused," which he and Rafferty attribute to important limitations in study design, including lack of low-calcium contrast groups and the fact that body weight/body composition is often a secondary endpoint in studies designed and powered for a different outcome, typically bone health or blood pressure. Confusion has also arisen from the investigation of different interventions (dairy products, dairy calcium, dietary calcium, supplemental calcium), making it difficult to compare and interpret studies. This creates an opportunity for the proposed Dairy and Weight Loss (DAWL) study, with its focus on whole dairy product consumption, to help clear up the confusion surrounding this issue.

**Hypotheses

Overweight/obese, low habitual dairy consuming, premenopausal women randomized to an energy-restricted weight loss diet containing ≥4 servings/day of dairy products (milk, yogurt, cheese) for 16 weeks will lose more body fat than those randomized to an isocaloric diet containing ≤1 servings/day of dairy products.


Condition Intervention Phase
Obesity
Overweight
 Other: Low dairy
Other: High dairy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diet and Weight Loss Study - a Weight Loss Trial to Determine Whether Dairy Products Augment Weight Loss for Adults Following an Energy-restricted Weight Loss Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Guelph:

Primary Outcome Measures:
  • Body fat [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Whole body fat will be measured at baseline (Week 0) and follow-up (Week 16) by dual energy x-ray absorptiometry


Secondary Outcome Measures:
  • Body weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The investigators will measure body weight every 2 weeks during the trial

  • Body mass index (BMI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Body mass is weight (in kg) divided by height (in m2), to be measured every 2 weeks

  • Waist and hip circumference [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The investigators will measure waist and hip circumference, using a measuring tape, every 2 weeks throughout the trial.

  • Fat-free mass [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Similar to fat mass, the investigators will measure fat-free mass at weeks 0 and 16, using dual energy x-ray absorptiometry

  • Biochemistry [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The investigators will measure various biochemical variables at weeks 0 and 16. These will include: glucose, insulin, lipid panel (triglyeride, total cholesterol, HDL cholesterol, LDL cholesterol), vitamin D, parathyroid hormone, C-reactive protein, conjugated linoleic acid concentrations of red blood cells, and hepatic lipase and lipoprotein lipase

  • Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The investigators will measure blood pressure every two weeks during the study.


Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counselling
These participants will be assigned to a 500 kcal/day energy-restricted diet that is low in dairy products (no more than 1 serving per day).
 Other: Low dairy
No more than 1 serving per day
Experimental: High dairy
These participants will be assigned a 500 kcal/day energy-restricted diet that is high in dairy (4 or more servings per day).
 Other: High dairy
4 or more servings per day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy adult premenopausal women with a Body Mass Index (BMI) equal to or greater than 25 kg/m2
  • Age 18 to 50 years
  • Healthy, to be determined from a background health questionnaire and a screening blood panel
  • Willing to comply with study protocol
  • able to visit laboratory regularly throughout the study (therefore must live within reasonable driving distance of the University of Guelph)

Exclusion Criteria:

  • Presence of any disease which may interfere with study outcomes including cardiovascular disease, diabetes, cancer, thyroid problem, renal disease, liver disease
  • not be willing to comply with study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337895

Locations
Canada, Ontario
Body Composition and Metabolism Lab, University of Guelph
Guelph, Ontario, Canada, N1G 2W1
Sponsors and Collaborators
University of Guelph
Purdue University
University of Saskatchewan
Investigators
Principal Investigator: Andrea C. Buchholz, PhD, RD University of Guelph
  More Information

Additional Information:
This is the lab's website. It will be updated with study information once funding received and study has started.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Andrea Buchholz, University of Guelph
ClinicalTrials.gov Identifier: NCT01337895     History of Changes
Other Study ID Numbers: 11MR010
Study First Received: April 15, 2011
Last Updated: November 10, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Guelph:
Dairy
obesity
overweight
weight loss
adults

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 17, 2013