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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02148224
Other study ID # 01-NRC-04-2014
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 20, 2014
Last updated May 22, 2014
Start date April 2014
Est. completion date May 2014

Study information

Verified date May 2014
Source Nutrifood Research Center, Jakarta, Indonesia
Contact n/a
Is FDA regulated No
Health authority Indonesia: Departement Kesehatan (Department of Health)
Study type Observational

Clinical 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 index values. This study aims to determine whether body composition parameters, as subject-specific factor, correlate with glycemic index values.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- age between 20-40 years

- fasting blood glucose 70-100 mg/dL

- Indonesians

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Indonesia Nutrifood Research Center Propinsi DKI Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Nutrifood Research Center, Jakarta, Indonesia

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

Carbohydrates in human nutrition. Report of a Joint FAO/WHO Expert Consultation. FAO Food Nutr Pap. 1998;66:1-140. — View Citation

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. Epub 2006 Jul 12. — View Citation

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. Erratum in: J Clin Endocrinol Metab. 2012 Jun;97(6):2203. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
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