NCT02625350

Brief Summary

Glycemic index is commonly used as a method to determine the effect of a food to blood glucose. Despite its carbohydrate and fat content, instant noodle is very popular in Asia, including Indonesia. Based on the serving method, there are instant noodle without and with soup. Studies have shown that water content of a meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. However none specifically studied instant noodles nor the additional water content as soup (not incorporated in the food matrix). Therefore, this study aims to determine whether the serving method of instant noodle (with and without soup) may influence the glycemic response and glycemic index value of the meal.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2015

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

First Submitted

Initial submission to the registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

December 1, 2015

Last Update Submit

December 4, 2015

Conditions

Healthy

Keywords

instant noodlewater contentglycemic indexserving method

Outcome Measures

Primary Outcomes (1)

  • Changes in 2-h postprandial blood glucose level

    blood glucose level will be measured in several time points (12-h fasting, 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, and 120 min after sample consumption)

    through study completion, an average of 1 month

Secondary Outcomes (1)

  • Incremental area under the curve (IAUC) of postprandial blood glucose level

    through study completion, an average of 1 month

Study Arms (3)

Instant noodle without soup

EXPERIMENTAL

Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes and drained

Other: Instant noodle without soup

Instant noodle with soup

EXPERIMENTAL

Instant noodle with 50 gram available carbohydrate per serving; cooked with 500 ml of water for 6 minutes, drained, and given additional 250 ml of water as soup

Other: Instant noodle with soup

Glucose reference

EXPERIMENTAL

250 ml glucose solution with 50 gram available carbohydrate per serving, used as reference

Other: Glucose reference

Interventions

Instant noodle without soupOTHER

First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle without soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

Instant noodle without soup
Instant noodle with soupOTHER

First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle with soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

Instant noodle with soup
Glucose referenceOTHER

First, fasting blood glucose was measured. Then, subjects consumed the glucose reference and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

Glucose reference

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20-40 years
  • Fasting blood glucose 70-99 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

Related Publications (4)

  • 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

  • Young KWH, Wolever TMS. Effect of volume and type of beverage consumed with a standard test meal on postprandial blood glucose responses. Nutrition Research 18(11): 1857-1863, 1998

    RESULT

  • Torsdottir I, Andersson H. Effect on the postprandial glycaemic level of the addition of water to a meal ingested by healthy subjects and type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1989 Apr;32(4):231-5. doi: 10.1007/BF00285289.

    PMID: 2759361RESULT

  • Gregersen S, Rasmussen O, Winther E, Hermansen K. Water volume and consumption time: influence on the glycemic and insulinemic responses in non-insulin-dependent diabetic subjects. Am J Clin Nutr. 1990 Sep;52(3):515-8. doi: 10.1093/ajcn/52.3.515.

    PMID: 2203255RESULT

Study Officials

  • Vanessa Yolanda, Ssi

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR

  • Lina Antono, MSc

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR

  • Astri Kurniati, MAppSc

    Nutrifood Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12