NCT02392819

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

March 2, 2015

Last Update Submit

September 2, 2015

Conditions

Postprandial Blood Glucose Regulation

Outcome Measures

Primary Outcomes (1)

  • blood glucose

    capillary blood glucose concentrations are determined at fasting and then repeatedly after a standardised breakfast

    4 hours

Secondary Outcomes (2)

  • serum insulin

    4 hours

  • Mood as measured by ratings on 100 mm visual analog scales( VAS rating scales)

    4 hours

Study Arms (2)

test product

EXPERIMENTAL

Arm: Panax ginseng

Dietary Supplement: Panax ginseng

placebo product

PLACEBO COMPARATOR

Arm: a placebo with similar appearance but without Panax ginseng. The tablet include all the other non-active bulk ingredients.

Dietary Supplement: Placebo

Interventions

Panax ginsengDIETARY_SUPPLEMENT

Pananx ginseng is provided prior to a standardised breakfast, effects on test variables are determined at fasting and repeatedly postprandially the breakfast

test product
PlaceboDIETARY_SUPPLEMENT
placebo product

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food for Health Science Centre, Medicon Village

Lund, , SE-223 81 LUND, Sweden

Location

MeSH Terms

Interventions

Asian ginseng

Study Officials

  • Anne C Nilsson, PhD

    Food for Health science Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 19, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

SE(1)