Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

NCT ID: NCT01944579

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-04-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Control-Blackberry

Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries.

Group Type: EXPERIMENTAL

Blackberries

Intervention Type: OTHER

Participants will receive blackberries as part of a controlled diet.

Control

Intervention Type: OTHER

Participants will receive a control food (jello) as part of a controlled diet.

Blackberry-Control

Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello).

Group Type: EXPERIMENTAL

Blackberries

Intervention Type: OTHER

Participants will receive blackberries as part of a controlled diet.

Control

Intervention Type: OTHER

Participants will receive a control food (jello) as part of a controlled diet.

Interventions

Blackberries

Participants will receive blackberries as part of a controlled diet.

Intervention Type: OTHER

Control

Participants will receive a control food (jello) as part of a controlled diet.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Janet Novotny

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Janet A Novotny, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS40

Identifier Type: -

Identifier Source: org_study_id