DAWL (Dairy and Weight Loss) Study

NCT01337895 | Withdrawn Phase 4

• 1 other identifier: 11MR010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. \*\*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.

Conditions

Obesity; Overweight

Keywords

Dairy; obesity; overweight; weight loss; adults

Outcome Measures

Primary Outcomes (1)

• Body fat

  Whole body fat will be measured at baseline (Week 0) and follow-up (Week 16) by dual energy x-ray absorptiometry

  16 weeks

Secondary Outcomes (6)

• Body weight

  16 weeks

• Body mass index (BMI)

  16 weeks

• Waist and hip circumference

  16 weeks

• Fat-free mass

  16 weeks

• Biochemistry

  16 weeks

Study Arms (2)

Lifestyle counselling

ACTIVE COMPARATOR

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

High dairy

EXPERIMENTAL

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

Interventions

Low dairy OTHER

No more than 1 serving per day

Lifestyle counselling

High dairy OTHER

4 or more servings per day

High dairy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead
• Purdue University: collaborator
• University of Saskatchewan: collaborator

Study Sites (1)

Body Composition and Metabolism Lab, University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Andrea C. Buchholz, PhD, RD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 11, 2011

Record last verified: 2011-08

Locations

CA (1)