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Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01944579
First received: September 12, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Other: Blackberries
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in fecal microbiota [ Time Frame: 0 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.


Secondary Outcome Measures:
  • Change in blackberry nutrients & metabolites [ Time Frame: 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in gene expression [ Time Frame: 0 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Gene expression in whole blood will be evaluated at the beginning and end of each diet period, through global gene expression using the Affymetrix platform. Changes in specific genes observed with global gene expression technology will be confirmed through RT-PCR.

  • Change in metabolomics [ Time Frame: 0 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Blood, urine, and feces will be analyzed by a technique called metabolomics, which is a broad sampling of metabolites.

  • Change in biomarkers of cancer [ Time Frame: 0 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Biomarkers of cancer risk such as oxidative stress and inflammatory markers will be analyzed at the beginning and end of each diet period.

  • Change in lipopolysaccharide [ Time Frame: 0 weeks, 4 weeks ] [ Designated as safety issue: No ]
    Lipopolysaccharide will be measured in the blood as a measure of gut leakiness.


Enrollment: 46
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Blackberries
Participants will receive blackberries as part of a controlled diet.
Other: Control
Participants will receive a control food (jello) as part of a controlled diet.
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).
Other: Blackberries
Participants will receive blackberries as part of a controlled diet.
Other: Control
Participants will receive a control food (jello) as part of a controlled diet.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944579

Locations
United States, Maryland
Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20906
Sponsors and Collaborators
Janet Novotny
Investigators
Principal Investigator: Janet A Novotny, Ph.D. USDA Beltsville Human Nutrition Research Center
  More Information

No publications provided

Responsible Party: Janet Novotny, Research Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01944579     History of Changes
Other Study ID Numbers: HS40
Study First Received: September 12, 2013
Last Updated: July 21, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014