Efficacy and Feasibility of an Intermittent Weight Loss Program.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Feasibility of an Intermittent Weight Loss Program: A Pilot Study.

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: calorie controlled diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: calorie controlled diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Caloric restriction, Intermittent diet, Obesity, Postmenopausal women