Maximizing the Anti-inflammatory Effects of Strawberry Bioavailability

NCT01856153 | Completed

• 1 other identifier: 2013-044
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective is to determine if the efficacy of strawberries delivering polyphenols to prevent metabolic inflammation will be influenced by timing of consumption relative to meal intake. Secondary objective is to characterize the relative bioavailability and absorption profile of strawberry polyphenols consumed with meal or at alternatives times around a meal (2 hours before the meal ad 2 hours after the meal). Third objective is to determine the bioavailability/absorption profile of strawberry polyphenols and its relationship with the anti-inflammatory mechanism of action of strawberry constituents.

Conditions

Overweight; Healthy

Keywords

Bioavailability; Strawberry polyphenols; Time Influence

Outcome Measures

Primary Outcomes (1)

• Changes in plasma polyphenol concentrations over 10 hours after strawberry beverage consumption at different time points.

  The timing influence of strawberry consumption on bioavailability of strawberry polyphenols in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).

  10 hours

Secondary Outcomes (1)

• Changes in inflammation markers over 10 hours after strawberry beverage consumption at different time points.

  10 hours

Other Outcomes (2)

• Changes in oxidative stress markers over 10 hours after strawberry beverage consumption at different time points.

  10 hours

• Changes in metabolic markers over 10 hours after strawberry beverage consumption at different time points.

  10 hours

Study Arms (3)

Before meal

OTHER

Strawberry-Placebo-Placebo

Dietary Supplement: Before meal

With Meal

OTHER

Placebo-Strawberry-Placebo

Dietary Supplement: With Meal

After Meal

OTHER

Placebo-Placebo-Strawberry

Dietary Supplement: After meal

Interventions

Before meal DIETARY_SUPPLEMENT

Before meal

With Meal DIETARY_SUPPLEMENT

With Meal

After meal DIETARY_SUPPLEMENT

After Meal

Eligibility Criteria

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

You may qualify if:

• years of age and older
• Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
• Nonsmoker
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol
• Weight stable: not gained or lost weight +/- 5 kg in previous 3 months

You may not qualify if:

• Men and women who smoke
• Past smokers: abstinence for minimum 2 years
• Men and women with known or suspected food intolerance, allergies or hypersensitivity
• Men and women known to have/diagnosed with diabetes mellitus
• Men and women who have fasting blood glucose concentrations \> 125mg/dL
• Men and women who have uncontrolled blood pressure \>140 mmHg/90 mmHg
• Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
• Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study
• Women who are lactating
• Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
• Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
• Men and women who are vegans
• Substance (alcohol or drug) abuse within the last 2 years.
• Excessive coffee and tea consumers (\> 4 cups/d)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• California Strawberry Commission: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

Meals; Postprandial Period

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 17, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)