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Trial record 37 of 37 for:    conjugated linoleic acid

DAWL (Dairy and Weight Loss) Study (DAWL)

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. Identifier: NCT01337895
Recruitment Status : Withdrawn (Grant not funded, study will not launch)
First Posted : April 19, 2011
Last Update Posted : November 11, 2011
Purdue University
University of Saskatchewan
Information provided by:
University of Guelph

Brief Summary:
  • 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.


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 or disease Intervention/treatment Phase
Obesity Overweight Other: Low dairy Other: High dairy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Body fat [ Time Frame: 16 weeks ]
    Whole body fat will be measured at baseline (Week 0) and follow-up (Week 16) by dual energy x-ray absorptiometry

Secondary Outcome Measures :
  1. Body weight [ Time Frame: 16 weeks ]
    The investigators will measure body weight every 2 weeks during the trial

  2. Body mass index (BMI) [ Time Frame: 16 weeks ]
    Body mass is weight (in kg) divided by height (in m2), to be measured every 2 weeks

  3. Waist and hip circumference [ Time Frame: 16 weeks ]
    The investigators will measure waist and hip circumference, using a measuring tape, every 2 weeks throughout the trial.

  4. Fat-free mass [ Time Frame: 16 weeks ]
    Similar to fat mass, the investigators will measure fat-free mass at weeks 0 and 16, using dual energy x-ray absorptiometry

  5. Biochemistry [ Time Frame: 16 weeks ]
    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

  6. Blood pressure [ Time Frame: 16 weeks ]
    The investigators will measure blood pressure every two weeks during the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01337895

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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
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Principal Investigator: Andrea C. Buchholz, PhD, RD University of Guelph

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Responsible Party: Andrea Buchholz, University of Guelph Identifier: NCT01337895     History of Changes
Other Study ID Numbers: 11MR010
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: August 2011
Keywords provided by University of Guelph:
weight loss
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes