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

Postprandial Blood Glucose Regulation Clinical Trial

Official title:

Food Design for Improved Cognitive Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392819
• Other study ID #: LundU
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: September 2, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postprandial Blood Glucose Regulation

Intervention

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

Locations

Country	Name	City	State
Sweden	Food for Health Science Centre, Medicon Village	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose	capillary blood glucose concentrations are determined at fasting and then repeatedly after a standardised breakfast	4 hours	No
Secondary	serum insulin	capillary serum insulin concentrations are determined at fasting and then repeatedly after a standardised breakfast	4 hours	No
Secondary	Mood as measured by ratings on 100 mm visual analog scales( VAS rating scales)	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	No