Raspberries and Postprandial Metabolism

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403582
• Other study ID #: HE1465
• Status: Completed
• Phase: N/A
• First received: January 5, 2018
• Last updated: January 10, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes

Exclusion Criteria:

• not having type 2 diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Raspberries
250g frozen whole red raspberries

Locations

Country	Name	City	State
United States	Oklahoma State University	Stillwater	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose	Postprandial blood glucose will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries	postprandial 4 hours
Primary	Postprandial blood lipids	Postprandial blood lipids will be measured at fasting, 1, 2 and 4 hours following meals with or without raspberries	postprandial 4 hours
Secondary	Postprandial inflammation	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