Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Blackberries; Other: Control

• Registration Number: NCT01944579
• Lead Sponsor: Janet Novotny

Brief Summary

Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-17
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blackberry-Control	Blackberries	Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello).
Control-Blackberry	Blackberries	Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries.
Control-Blackberry	Control	Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries.
Blackberry-Control	Control	Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello).

Primary Outcome Measures

Name	Time	Method
Change in fecal microbiota	0 weeks, 4 weeks	Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.

Secondary Outcome Measures

Name	Time	Method
Change in blackberry nutrients & metabolites	0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes

Trial Locations

Locations (1)

Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States