Raspberries and Postprandial Metabolism

NCT ID: NCT03403582

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

A high-fat break fast meal with no raspberries.

Group Type NO_INTERVENTION

No interventions assigned to this group

Raspberry arm

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

Group Type EXPERIMENTAL

Raspberries

Intervention Type OTHER

250g frozen whole red raspberries

Interventions

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Raspberries

250g frozen whole red raspberries

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes

Exclusion Criteria

* not having type 2 diabetes
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Arpita Basu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oklahoma State University

Stillwater, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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HE1465

Identifier Type: -

Identifier Source: org_study_id

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