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Raspberries and Postprandial Metabolism

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Raspberries
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • type 2 diabetes

Exclusion Criteria:

  • not having type 2 diabetes

Sites / Locations

  • Oklahoma State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Raspberry arm

Arm Description

A high-fat break fast meal with no raspberries.

A high-fat break fast meal with raspberries (250g frozen)

Outcomes

Primary Outcome Measures

Postprandial blood glucose
Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Postprandial blood lipids
Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries

Secondary Outcome Measures

Postprandial inflammation
Postprandial C-reactive protein and interleukins will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries

Full Information

First Posted
January 5, 2018
Last Updated
January 10, 2018
Sponsor
Oklahoma State University
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1. Study Identification

Unique Protocol Identification Number
NCT03403582
Brief Title
Raspberries and Postprandial Metabolism
Official Title
Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
A high-fat break fast meal with no raspberries.
Arm Title
Raspberry arm
Arm Type
Experimental
Arm Description
A high-fat break fast meal with raspberries (250g frozen)
Intervention Type
Other
Intervention Name(s)
Raspberries
Intervention Description
250g frozen whole red raspberries
Primary Outcome Measure Information:
Title
Postprandial blood glucose
Description
Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Time Frame
postprandial 4 hours
Title
Postprandial blood lipids
Description
Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Time Frame
postprandial 4 hours
Secondary Outcome Measure Information:
Title
Postprandial inflammation
Description
Postprandial C-reactive protein and interleukins will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries
Time Frame
postprandial 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: type 2 diabetes Exclusion Criteria: not having type 2 diabetes
Facility Information:
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Raspberries and Postprandial Metabolism

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