NCT02148224

Brief Summary

Glycemic index concept is widely used to determine impact of a food to blood glucose. Although the previous studies showed that glycemic index did not seem to be related with subject-specific factors, currently several studies found conflicting results on the relationship of subjects' characteristics and glycemic index values. This study aims to determine whether body composition parameters, as subject-specific factor, correlate with glycemic index values.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

May 20, 2014

Last Update Submit

May 22, 2014

Conditions

Keywords

glycemic indexbody composition

Outcome Measures

Primary Outcomes (2)

  • correlation between glycemic value and body composition

    Study the correlation between the glycemic values (produced from comparing area under the curve value after ingestion of glucose standard and after consuming test sample) and subjects' body composition parameters: weight, muscle mass, fat mass, percent body fat, BMI, Waist-hip ratio, visceral fat, and estimated trunk fat. Pearson's r and its significance value (p-value) will be reported.

    baseline

  • glycemic index values of instant noodle

    The glycemic index is a calculated from measurements of area under the glucose curve after the food is eaten, divided by the corresponding area after the control food is eaten. The value is multiplied by 100 to represent a percentage of the control food.

    2 hours postprandial glucose

Study Arms (1)

healthy without diabetes

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be selected from a group of office workers fulfilling inclusion criteria.

You may qualify if:

  • age between 20-40 years
  • fasting blood glucose 70-100 mg/dL
  • Indonesians

You may not qualify if:

  • having diabetes
  • smoking
  • if women, pregnant or lactating
  • being allergic to food used in this study
  • having gastrointestinal disturbance
  • in regular medication
  • refusal to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrifood Research Center

Propinsi DKI Jakarta, DKI Jakarta, 13920, Indonesia

Location

Related Publications (3)

  • Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. No abstract available.

    PMID: 9743703BACKGROUND
  • Srikanthan P, Karlamangla AS. Relative muscle mass is inversely associated with insulin resistance and prediabetes. Findings from the third National Health and Nutrition Examination Survey. J Clin Endocrinol Metab. 2011 Sep;96(9):2898-903. doi: 10.1210/jc.2011-0435. Epub 2011 Jul 21.

    PMID: 21778224BACKGROUND
  • Mettler S, Lamprecht-Rusca F, Stoffel-Kurt N, Wenk C, Colombani PC. The influence of the subjects' training state on the glycemic index. Eur J Clin Nutr. 2007 Jan;61(1):19-24. doi: 10.1038/sj.ejcn.1602480. Epub 2006 Jul 12.

    PMID: 16835599BACKGROUND

Study Officials

  • Kamalita Pertiwi, STP

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR
  • Astri Kurniati, MAppSc

    Nutrifood Research Center

    STUDY CHAIR
  • Lina Antono, MSc

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR
  • Susana Susana, MSc, PDEng

    Nutrifood Research Center

    STUDY CHAIR
  • Mardi Wu, MBA

    Nutrifood Research Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition and Health Science Associate

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 28, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations