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HealthyNCT02148224

Relationship of Glycemic Index Values and Subjects' Body Composition Parameters

An observational study of Healthy, run by Nutrifood Research Center, Jakarta, Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
30 participants
Where
1 siteIndonesia
Study dates
Apr 2014to May 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Nutrifood Research Center

    Propinsi DKI Jakarta, DKI Jakarta, 13920

Other trials in Indonesia

About this study

Official title: Correlation of Glycemic Index Values and Subjects' Body Composition Parameters

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.

Read the detailed description

Glycemic index methods are performed according to Food and Agricultural Organization/WHO recommendations.

Conditions
Healthy
Keywords
glycemic index, body composition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02148224
Study groupRoleWhat they receive
healthy without diabetesNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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.

    Measured: 2 hours postprandial glucose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2014 (estimated)
  4. Study completionMay 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02148224
Sponsor's protocol ID
01-NRC-04-2014
Status last verified
May 2014
First submitted
20 May 2014
Last updated
28 May 2014
Results posted
No
Data monitoring committee
No

Publications

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

    PubMed 9743703

  • 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.

    PubMed 21778224

  • 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.

    PubMed 16835599

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Nutrifood Research Center, Jakarta, Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between glycemic value and body composition (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02148224, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.

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