Raspberries and Postprandial Metabolism

January 10, 2018 updated by: Arpita Basu, Oklahoma State University

Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus

Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods:

Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values.

Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group

Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:

  • systolic blood pressure and diastolic blood pressure
  • large artery elasticity index and small artery elasticity index
  • systemic vascular resistance

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Stillwater, Oklahoma, United States, 74078
        • Oklahoma State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2 diabetes

Exclusion Criteria:

  • not having type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
A high-fat break fast meal with no raspberries.
Experimental: Raspberry arm
A high-fat break fast meal with raspberries (250g frozen)
250g frozen whole red raspberries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial blood glucose
Time Frame: postprandial 4 hours
Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
postprandial 4 hours
Postprandial blood lipids
Time Frame: postprandial 4 hours
Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
postprandial 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial inflammation
Time Frame: postprandial 4 hours
Postprandial C-reactive protein and interleukins will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
postprandial 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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