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OpenTrials
Completed

NCT Number: NCT03403582

Raspberries and Postprandial Metabolism

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes

Exclusion criteria

  • not having type 2 diabetes

Treatment and study plan

Raspberries

Other

250g frozen whole red raspberries

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Official study title

Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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