Effects on Metabolism and Cognitive Functions of a Commonly Used Commercial Food Supplement

September 2, 2015 updated by: Anne Nilsson, Lund University

Food Design for Improved Cognitive Performance

This project evaluate effects of a commonly used food supplement on glucose metabolism and cognitive function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The test product has previously been suggested to elicit beneficial effects on glucose metabolism and cognitive performance. The purpose with this study is to evaluate metabolic effects and effects on mood variables of the test product provided at breakfast. Test variables are determined at fating and postprandial a standardised breakfast. The results are compared with effects after a placebo product.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, , SE-223 81 LUND
        • Food for Health Science Centre, Medicon Village

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

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 40-60 years, normal BMI, healthy, non-smokers

Exclusion Criteria:

  • metabolic disorders or gastro- intestinal disease, intake of probiotics- or antibiotics during the last 2 weeks prior to the study.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test product
Arm: Panax ginseng
Dietary supplement: Panax ginseng
Pananx ginseng is provided prior to a standardised breakfast, effects on test variables are determined at fasting and repeatedly postprandially the breakfast
Placebo Comparator: placebo product
Arm: a placebo with similar appearance but without Panax ginseng. The tablet include all the other non-active bulk ingredients.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 4 hours
capillary blood glucose concentrations are determined at fasting and then repeatedly after a standardised breakfast
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum insulin
Time Frame: 4 hours
capillary serum insulin concentrations are determined at fasting and then repeatedly after a standardised breakfast
4 hours
Mood as measured by ratings on 100 mm visual analog scales( VAS rating scales)
Time Frame: 4 hours
measures of 6 mood variables (sad-glad, depressed-happy, displeased-pleased, dull-peppy, passive-Active, sleepy-awake) repeatedly in the postprandial period after breakfast
4 hours

Collaborators and Investigators

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

Sponsor

Lund University

Collaborators

Anti-Diabetic Food Centre

Investigators

  • Principal Investigator: Anne C Nilsson, PhD, Food for Health science Centre

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

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 2, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LundU

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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