Efficacy and Feasibility of an Intermittent Weight Loss Program.

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: 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 Type: Interventional
• Enrollment: 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Institut universitaire de gériatrie de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Martin Brochu, PhD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion: June 1, 2007

Study Registration Dates

• First Submitted: November 1, 2006
• First Submitted That Met QC Criteria: November 1, 2006
• First Posted (Estimate): November 2, 2006

Study Record Updates

• Last Update Posted (Estimate): November 2, 2006
• Last Update Submitted That Met QC Criteria: November 1, 2006
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: Obesity; Diet; Caloric restriction; Postmenopausal women; Intermittent diet
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: FRSQ-5574