Efficacy and Feasibility of an Intermittent Weight Loss Program.

NCT00395356 | Completed

• 1 other identifier: FRSQ-5574
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Diet; Caloric restriction; Intermittent diet; Obesity; Postmenopausal women

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• 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

Interventions

calorie controlled diet BEHAVIORAL

Eligibility Criteria

• Age: 51 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Institut universitaire de gériatrie de Sherbrooke

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Martin Brochu, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 2, 2006
• Study Start: September 1, 2005
• Study Completion: June 1, 2007
• Last Updated: November 2, 2006

Record last verified: 2006-11

Locations

CA (1)