Effects of Whole Grain Rye on Metabolic Risk Markers and Mood

October 2, 2017 updated by: Anne Nilsson, Lund University

Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers

The purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • BMI 19-28
  • plasma glucose < 6.1 mmol/L
  • non smooker

Exclusion Criteria:

  • known metabolic diseases
  • known gastrointestinal disorders
  • known cognitive decline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: whole grain
Other: whole grain
whole grain rye
Other: refrence
white wheat based product
Other: reference
white wheat bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive performance
Time Frame: postprandial 0-180 min after breakfast
test of working memory capacity
postprandial 0-180 min after breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose tolerance
Time Frame: 0-180 min after breakfast
postprandial glucose concentrations
0-180 min after breakfast

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

October 2, 2017

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 6, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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