- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403582
Raspberries and Postprandial Metabolism
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
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Stillwater, Oklahoma, United States, 74078
- Oklahoma State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- type 2 diabetes
Exclusion Criteria:
- not having type 2 diabetes
Study Plan
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.
|
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Experimental: Raspberry arm
A high-fat break fast meal with raspberries (250g frozen)
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250g frozen whole red raspberries
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE1465
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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