- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01255228
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese Women
Effect of Low Glycemic Index Diet on Body Composition and Mechanism of Obese
Excessive body weight and obesity have reached epidemic proportions over the last few decades, which may cause many chronic diseases. Maintaining a healthy life style could decrease the risk for obesity, metabolic syndrome and cardiovascular disease. The study aimed to evaluate long-term low glycemic index (GI) diet intervention on lipid profile, body composition and the mechanism of obese women. The pilot study will recruit twenty healthy subjects, and served test food to determine low GI food. In the experiment period, twenty women age from 20-50 years will be recruited. To be included in the study, subjects should have a BMI above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline > 80 cm). Before dietary intervention, participants will receive food choice table and dietary questionnaires to record their dietary intake.
The study will be a randomized, crossover, controlled clinical trails. The experiment period have six weeks, each participants will provide low GI diet (lunch and dinner). On the 0, 3, 6 week, subjects will measurement their body composition (body weight, body mass, waist and hip circumferences) and collect fasting blood samples to analysis the lipid profile, free fatty acid, blood sugar, insulin, adiponectin, leptin and fatty acid synthesis enzymes. Statistical analysis will be performed by paired t-test. The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women.
Studieöversikt
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Taipei, Taiwan
- Taipei Medical University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- BMI above 24 kg/m2, or the either one ( fat mass ≧ 30% or waistline > 80 cm )
Exclusion Criteria:
- Cardiovascular disease
- type 2 diabetes mellitus or impaired glucose tolerance
- serious liver or renal disease, gastro-intestinal disease
- proceed serious diet control for formerly three months
- take any supplemental food products or medications known to influence lipid or carbohydrate metabolism
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Low glycemic index diet
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
|
Experimentell: diet intervention
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
the effect of body composition ( body weight,body mass,waist and hip circumferences )
Tidsram: 6 week
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6 week
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Jen-Fang Liu, Taipei Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
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
- 99055
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