Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

NCT01944579 | Completed

• 1 other identifier: HS40
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in blackberry nutrients & metabolites

  0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes

Other Outcomes (4)

• Change in gene expression

  0 weeks, 4 weeks

• Change in metabolomics

  0 weeks, 4 weeks

• Change in biomarkers of cancer

  0 weeks, 4 weeks

Study Arms (2)

Control-Blackberry

EXPERIMENTAL

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

Other: Blackberries; Other: Control

Blackberry-Control

EXPERIMENTAL

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

Other: Blackberries; Other: Control

Interventions

Blackberries OTHER

Participants will receive blackberries as part of a controlled diet.

Blackberry-Control; Control-Blackberry

Control OTHER

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

Blackberry-Control; Control-Blackberry

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janet Novotny: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20906, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Janet A Novotny, Ph.D.

  USDA Beltsville Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

US (1)