Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria
Klíčová slova
Abstraktní
Termíny
| Poslední ověření: | 06/30/2014 |
| První předloženo: | 09/11/2013 |
| Odhadovaná registrace vložena: | 09/11/2013 |
| První zveřejnění: | 09/16/2013 |
| Poslední aktualizace byla odeslána: | 07/20/2014 |
| Poslední aktualizace zveřejněna: | 07/21/2014 |
| Aktuální datum zahájení studie: | 08/31/2013 |
| Odhadované datum dokončení primární: | 03/31/2014 |
| Odhadované datum dokončení studie: | 03/31/2014 |
Stav nebo nemoc
Intervence / léčba
Other: Blackberries
Other: Control
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Control-Blackberry Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries. | |
| Experimental: Blackberry-Control Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello). |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 25 Years Na 25 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: - 25-75 years old Exclusion Criteria: - Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione) - Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals - Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study - Type 2 diabetes requiring the use of oral antidiabetic agents or insulin - Fasting triglycerides greater than 300 mg/dL - Fasting glucose greater than 126 mg/dL - History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) - Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity - Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months). - Use of any tobacco products in past 3 months - Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study - Known (self-reported) allergy or adverse reaction to blackberries or other study foods - Unable or unwilling to give informed consent or communicate with study staff - Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion) - Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol |
Výsledek
Primární výsledná opatření
1. Change in fecal microbiota [0 weeks, 4 weeks]
Měření sekundárních výsledků
1. Change in blackberry nutrients & metabolites [0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes]
Další výsledková opatření
1. Change in gene expression [0 weeks, 4 weeks]
2. Change in metabolomics [0 weeks, 4 weeks]
3. Change in biomarkers of cancer [0 weeks, 4 weeks]
4. Change in lipopolysaccharide [0 weeks, 4 weeks]
