- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Quebec
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Sherbrooke, Quebec, Kanada, J1H 4C4
- Institut universitaire de gériatrie de Sherbrooke
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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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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Sekundära resultatmått
Resultatmått |
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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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Martin Brochu, PhD, Université de Sherbrooke
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FRSQ-5574
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