- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00395356
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.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Quebec
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Sherbrooke, Quebec, Canada, J1H 4C4
- Institut universitaire de gériatrie de Sherbrooke
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Body composition (fat mass and lean body mass): after 0, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
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Sekundære resultatmål
Resultatmål |
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Fasting lipids: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
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Resting metabolic rate: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
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Resting blood pressure: baseline, 5, 10, 15, 20 and 25 weeks, as well as 12-month post-intervention
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OGTT: baseline and 25 weeks
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Dietary habits: baseline,25 weeks and 12-month post-intervention
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Martin Brochu, PhD, Université de Sherbrooke
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FRSQ-5574
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .