Raspberries and Postprandial Metabolism

NCT03403582 | Completed

• 1 other identifier: HE1465
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Postprandial inflammation

  postprandial 4 hours

Study Arms (2)

Control arm

NO INTERVENTION

A high-fat break fast meal with no raspberries.

Raspberry arm

EXPERIMENTAL

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

Other: Raspberries

Interventions

Raspberries OTHER

250g frozen whole red raspberries

Raspberry arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• type 2 diabetes

You may not qualify if:

• not having type 2 diabetes

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 18, 2018
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)