NCT02876029

Brief Summary

The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

August 18, 2016

Last Update Submit

August 26, 2016

Conditions

Poor Glycemic Control

Outcome Measures

Primary Outcomes (1)

  • Glucose

    0-6 h

Secondary Outcomes (4)

  • Non-esterified fatty acids (NEFA)

    0-6 h

  • Triglycerides (TG)

    0-6 h

  • Appetite rating (Visual Analogue Scale)

    0-6 h

  • Insulin

    0-6 h

Study Arms (2)

Reference

OTHER

White wheat bread

Other: ReferenceOther: Test product

Test product

OTHER

Pasta

Other: ReferenceOther: Test product

Interventions

ReferenceOTHER

the reference product used

Also known as: WWB
ReferenceTest product
Test productOTHER

The test Product used

Also known as: Pasta
ReferenceTest product

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19-25

You may not qualify if:

  • Smoker, Diabetes, Gluten intolerance, vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Elin Östman, Ass prof

    Food for Health Science Centre (Medicon Village) - Lund University

    STUDY DIRECTOR

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
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 23, 2016

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

August 29, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share