Green Coffee Extract and Metabolic Syndrome
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StatoCompletato
Sponsor
National Nutrition and Food Technology Institute
TEST CLINICO: NCT02764957
BioSeek: NCT02764957
Parole chiave
Astratto
Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.
Date
| Ultimo verificato: | 07/31/2017 |
| Primo inviato: | 04/30/2016 |
| Iscrizione stimata inviata: | 05/03/2016 |
| Primo pubblicato: | 05/05/2016 |
| Ultimo aggiornamento inviato: | 08/24/2017 |
| Ultimo aggiornamento pubblicato: | 08/27/2017 |
| Data di inizio effettiva dello studio: | 11/30/2016 |
| Data di completamento primaria stimata: | 03/20/2017 |
| Data stimata di completamento dello studio: | 04/20/2017 |
Condizione o malattia
Metabolic Syndrome
Intervento / trattamento
Dietary Supplement: intervention
Dietary Supplement: control
Fase
Fase 2/Fase 3
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Active Comparator: intervention 400 mg green coffee extract capsules twice per day for 8 weeks The Green coffee extract is standardised with 45% total chlorogenic acid by HPLC | Dietary Supplement: intervention |
| Placebo Comparator: control placebo capsules twice per day for 8 weeks have identical appearance to Green coffee extract capsules and contain starch | Dietary Supplement: control |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: - Waist circumference>102 cm in men and >88 cm in women - Fasting blood glucose>100 mg/dL (5.6 mmol /L) - Systolic blood pressure>130 mmHg or diastolic blood pressure>85mmHg - Triglycerides> 150 mg/dL (1.7 mmol/L) Exclusion Criteria: - Insulin administration - Pregnancy and breastfeeding - regular consumption of coffee and green tea |
Risultato
Misure di esito primarie
1. fasting blood glucose [8 weeks]
Misure di esito secondarie
1. HOMA-IR [8 weeks]
2. blood pressure [8 weeks]
3. insulin [8 weeks]
4. hemoglubin A1c [8 weeks]
5. triglyceride [8 weeks]
