Blackberry Polyphenol Intake and Fuel Management

NCT01932879 | Completed

• 1 other identifier: HS44
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation, and this may be the mechanism by which body fatness is influenced by anthocyanin intake. Well-controlled studies in humans are lacking.

Conditions

Fuel Management

Outcome Measures

Primary Outcomes (1)

• Substrate oxidation

  Participants will stay in a room calorimeter for 23.5 hours.

  23.5 hours

Secondary Outcomes (1)

• Glucose tolerance test

  -15, 0, 30, 60, 90, 120, 180, 240 minutes

Study Arms (2)

Blackberry

EXPERIMENTAL

Participants will consume blackberries twice/day as part of a 1-week controlled diet.

Other: Blackberry

Control

OTHER

Participants will consume jello twice/day as part of a 1-week controlled diet.

Other: Jello

Interventions

Blackberry OTHER

Participants will be fed a higher fat, typical American diet for two 1-week periods. Participants must consume only and all food provided during the intervention periods.

Blackberry

Jello OTHER

Control

Eligibility Criteria

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

You may not qualify if:

• Younger than 25 years old or older than 75 years old
• Female
• Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)
• 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., phenylpropanalamine, 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
• Use of oral or IV antibiotics during the month preceding the study
• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 30, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (1)