Red Raspberries on Insulin Action and Oxidative Stress

NCT02479035 | Completed

• 1 other identifier: IRB2015-030
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the relative bioavailability and absorption/kinetic profile of red raspberry polyphenols consumed with a meal and further to determine the relationship of these findings on meal-associated metabolic- oxidative- and inflammatory- responses in relatively insulin sensitive and insulin resistant individuals.

Conditions

Insulin Resistant

Keywords

insulin sensitive; insulin resistant; red raspberry; polyphenols; bioavailability

Outcome Measures

Primary Outcomes (1)

• Changes in plasma metabolic markers over 8 h after consuming iso-caloric meals prepared with and without red raspberry

  The influence of red raspberry consumption on metabolic markers (insulin and glucose)

  8 hours

Secondary Outcomes (3)

• Characterization of plasma polyphenol metabolites and concentration differences over 8 after consuming iso-caloric meals with and without red raspberry

  8 hours

• Changes in fasting plasma metabolites over 24 h after consuming iso-caloric meals prepared with and without red raspberry

  24 hr

• Changes in fasting plasma metabolic markers over 24 h after consuming iso-caloric meals prepared with and without red raspberry

  24 hr

Other Outcomes (1)

• Changes in inflammation and oxidative markers over 8 after consuming iso-caloric meals prepared with and without red raspberry

  8 hours

Study Arms (3)

Red raspberry meal 1

ACTIVE COMPARATOR

\~125 g fresh weight (1 cup equivalent)

Dietary Supplement: Red raspberry meal 1

Red raspberry meal 2

ACTIVE COMPARATOR

\~250 g fresh weight (2 cup equivalent)

Dietary Supplement: Red raspberry meal 2

Control meal

PLACEBO COMPARATOR

0 g red raspberry

Dietary Supplement: Control meal

Interventions

Red raspberry meal 1 DIETARY_SUPPLEMENT

\~125 g fresh weight (1 cup equivalent)

Red raspberry meal 1

Red raspberry meal 2 DIETARY_SUPPLEMENT

\~250 g fresh weight (2 cup equivalent)

Red raspberry meal 2

Control meal DIETARY_SUPPLEMENT

0 g red raspberry

Control meal

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fasting blood sugar between 100-125 mg/dL and fasting insulin concentration ≥ 8 uIU/mL for Prediabetes,insulin-resistant group
• Fasting blood sugar \< 100 mg/dL and the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose \[in millimoles per liter\] × insulin \[in microunits per milliliter\]/22.5) values less than 1 for reference/control group.
• Aged between 20 to 60 years old male/female
• Non-smoker or Past smokers: abstinence for less than 2 years
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
• Not taking any medications or dietary supplements that would interfere with outcomes of the study.

You may not qualify if:

• Men and women who smoke
• Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
• Men and women known to have/diagnosed with diabetes mellitus
• Men and women who have fasting blood glucose concentrations ≥126 mg/dL
• 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.
• interfere with the outcomes of the study; e.g., antioxidant supplements, 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.
• Substance (alcohol or drug) abuse within the last 2 years.
• Excessive coffee and tea consumers (\> 4 cups/day)
• Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
• Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• Xiao D, Zhu L, Edirisinghe I, Fareed J, Brailovsky Y, Burton-Freeman B. Attenuation of Postmeal Metabolic Indices with Red Raspberries in Individuals at Risk for Diabetes: A Randomized Controlled Trial. Obesity (Silver Spring). 2019 Apr;27(4):542-550. doi: 10.1002/oby.22406. Epub 2019 Feb 14.

  PMID: 30767409 DERIVED

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: June 19, 2015
• First Posted: June 23, 2015
• Study Start: June 15, 2015
• Primary Completion: December 6, 2016
• Study Completion: April 2, 2018
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)