Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

Study Overview
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Brief Summary
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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
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Metabolic Syndrome

Intervention / Treatment
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* Other: Blackberries
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control-Blackberry<br>Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries. | Other: Blackberries<br>* Participants will receive blackberries as part of a controlled diet.<br>Other: Control<br>* Participants will receive a control food (jello) as part of a controlled diet.<br>|
| Experimental: Blackberry-Control<br>Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello). | Other: Blackberries<br>* Participants will receive blackberries as part of a controlled diet.<br>Other: Control<br>* Participants will receive a control food (jello) as part of a controlled diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal microbiota | Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period. | 0 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blackberry nutrients & metabolites |  | 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes |