Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944579
• Other study ID #: HS40
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: July 21, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Blackberries
Participants will receive blackberries as part of a controlled diet.
• Control
Participants will receive a control food (jello) as part of a controlled diet.

Locations

Country	Name	City	State
United States	Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Janet Novotny	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gene expression	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.	0 weeks, 4 weeks	No
Other	Change in metabolomics	Blood, urine, and feces will be analyzed by a technique called metabolomics, which is a broad sampling of metabolites.	0 weeks, 4 weeks	No
Other	Change in biomarkers of cancer	Biomarkers of cancer risk such as oxidative stress and inflammatory markers will be analyzed at the beginning and end of each diet period.	0 weeks, 4 weeks	No
Other	Change in lipopolysaccharide	Lipopolysaccharide will be measured in the blood as a measure of gut leakiness.	0 weeks, 4 weeks	No
Primary	Change in fecal microbiota	Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.	0 weeks, 4 weeks	No
Secondary	Change in blackberry nutrients & metabolites		0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes	No