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Efficacy and Feasibility of an Intermittent Weight Loss Program.

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ClinicalTrials.gov Identifier: NCT00395356
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : November 2, 2006
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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.

Condition or disease Intervention/treatment
Obesity Behavioral: calorie controlled diet

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Feasibility of an Intermittent Weight Loss Program: A Pilot Study.
Study Start Date : September 2005
Estimated Study Completion Date : June 2007

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
  2. Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
  3. Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
  4. OGTT: baseline and 25 weeks
  5. Dietary habits: baseline,25 weeks and 12-month post-intervention

Eligibility Criteria

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Ages Eligible for Study:   51 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00395356

Canada, Quebec
Institut universitaire de gériatrie de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 4C4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
Principal Investigator: Martin Brochu, PhD Université de Sherbrooke
More Information

ClinicalTrials.gov Identifier: NCT00395356     History of Changes
Other Study ID Numbers: FRSQ-5574
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: November 2006

Keywords provided by Université de Sherbrooke:
Caloric restriction
Intermittent diet
Postmenopausal women

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms