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Efficacy and Feasibility of an Intermittent Weight Loss Program.

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
calorie controlled diet
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Diet, Caloric restriction, Intermittent diet, Obesity, Postmenopausal women

Eligibility Criteria

51 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women who had stopped menstruating for more than 1 year
  • Waist circumference > 90 cm
  • Sedentary (< 2 times a week of structured exercise)
  • Non-smokers
  • Low to moderate alcohol consumers (< 2 drinks per day).

Exclusion Criteria:

  • We excluded subjects with the following conditions based on medical history and physical examination and on laboratory testing of kidney and liver functions, serum TSH, fasting glucose and lipid profile, and 75g-OGTT
  • Cardiovascular disease, peripheral vascular disease or stroke
  • Diabetes
  • Moderate to severe hypertension (resting blood pressure > 170/100 mm Hg);
  • Body weight fluctuation > 5 kg in the previous 6 months
  • Thyroid or pituitary disease
  • Hormonal replacement therapy at any time during the previous 6 months
  • Medication that could affect the metabolic profile

Sites / Locations

  • Institut universitaire de gériatrie de Sherbrooke

Outcomes

Primary Outcome Measures

Body composition (fat mass and lean body mass): after 0, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention

Secondary Outcome Measures

Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
OGTT: baseline and 25 weeks
Dietary habits: baseline,25 weeks and 12-month post-intervention

Full Information

First Posted
November 1, 2006
Last Updated
November 1, 2006
Sponsor
Université de Sherbrooke
Collaborators
Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT00395356
Brief Title
Efficacy and Feasibility of an Intermittent Weight Loss Program.
Official Title
Efficacy and Feasibility of an Intermittent Weight Loss Program: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Université de Sherbrooke
Collaborators
Fonds de la Recherche en Santé du Québec

4. Oversight

5. Study Description

Brief Summary
The goal of the study is to measure the effect of an approach including phases of active weight loss broken by weight stabilisation periods (named intermittent weight loss) on the metabolic profile. First, the intermittent weight loss approach will contribute to create an artificial transitory steady state during the weight loss treatment that will help to minimize the adverse effects of the standard approach on muscle mass and resting metabolic rate. Second, despite a comparable fat mass loss, the intermittent weight loss approach will improve the metabolic profile to a greater degree compared to the standard approach. Finally, the intermittent weight loss approach will be associated with less weight regain after the treatment since the beneficial effect on muscle mass and metabolic rate.
Detailed Description
Excessive levels of body fat are associated with metabolic disturbances predictive of an increased risk of coronary heart disease (CAD). It is presently unclear as to the magnitude of weight loss needed to accrue metabolic benefits. Despite the effectiveness of weight loss to reduce obesity levels, studies have shown that only minor decreases in body weight (5-10%) are needed to clinically improve CAD risk factors. Our data suggested that a 10% reduction in body weight is as effective in improving the metabolic profile as a 20% decrease in body weight. Thus, the question are : " Is it possible to further improve the metabolic profile over that 5-10% weight loss threshold?" and "Could several 5-10% body weight loss (intermittent weight loss approach) have additive effects on the metabolic profile?". We would like to follow-up on these observation to better understand 1) the association between weight loss and improvements in the metabolic profile and 2) why minor decreases in body composition and body fat distribution are as effective as more important reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Diet, Caloric restriction, Intermittent diet, Obesity, Postmenopausal women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
calorie controlled diet
Primary Outcome Measure Information:
Title
Body composition (fat mass and lean body mass): after 0, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Secondary Outcome Measure Information:
Title
Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Title
Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Title
Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
Title
OGTT: baseline and 25 weeks
Title
Dietary habits: baseline,25 weeks and 12-month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who had stopped menstruating for more than 1 year Waist circumference > 90 cm Sedentary (< 2 times a week of structured exercise) Non-smokers Low to moderate alcohol consumers (< 2 drinks per day). Exclusion Criteria: We excluded subjects with the following conditions based on medical history and physical examination and on laboratory testing of kidney and liver functions, serum TSH, fasting glucose and lipid profile, and 75g-OGTT Cardiovascular disease, peripheral vascular disease or stroke Diabetes Moderate to severe hypertension (resting blood pressure > 170/100 mm Hg); Body weight fluctuation > 5 kg in the previous 6 months Thyroid or pituitary disease Hormonal replacement therapy at any time during the previous 6 months Medication that could affect the metabolic profile
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Brochu, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de gériatrie de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

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Efficacy and Feasibility of an Intermittent Weight Loss Program.

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