Clinical trial NCT00395356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Diet
Caloric restriction
Intermittent diet
Obesity
Postmenopausal women
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2006-11-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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 outcomes:
measure: Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
measure: Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
measure: Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
measure: OGTT: baseline and 25 weeks
measure: Dietary habits: baseline,25 weeks and 12-month post-intervention
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Institut universitaire de gériatrie de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Martin Brochu, PhD
role: PRINCIPAL_INVESTIGATOR
References: