NCT02625363

Brief Summary

Glycemic index concept is widely used to determine impact of a food to blood glucose. Several studies showed that water content and intake after meal may influence glycemic response of the meal and thus have an effect on the result of GI measurement. Currently these studies found conflicting results. Therefore, this study aims to determine whether water intake, specifically after meal, may influence the glycemic response and glycemic index value of the meal.

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
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable healthy

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

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
15 days 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

1 month

First QC Date

November 16, 2015

Last Update Submit

December 4, 2015

Conditions

Healthy

Keywords

Glycemic IndexWater IntakeGlycemic Response

Outcome Measures

Primary Outcomes (2)

  • 2 h postprandial blood glucose level (Glycemic Response)

    fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min

  • Glycemic index value of meal (white bread)

    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 reference food.

    fasting 0 min, 15 min, 30 min, 45 min, 60 min, 90 min, 120 min

Study Arms (5)

Glucose Ref - Std

EXPERIMENTAL

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

Other: Glucose Ref - Std

Glucose Ref and 450 ml water

EXPERIMENTAL

250 ml glucose solution with 50 gram available carbohydrate per serving. Sample was consumed with additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption

Other: Glucose Ref and 450 ml water

White Bread with 250 ml water

EXPERIMENTAL

White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption

Other: White Bread with 250 ml water

White Bread and 700 ml water

EXPERIMENTAL

White bread with 50 gram available carbohydrate was consumed with 250 ml water immediately after meal consumption. Moreover, subjects given additional water intake @150 ml at 45, 75, and 105 minutes after meal consumption

Other: White Bread and 700 ml water

White Bread with 125 ml water (twice)

EXPERIMENTAL

Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes

Other: White Bread with 125 ml water (twice)

Interventions

Glucose Ref - StdOTHER

First, fasting blood glucose was measured. Then, subjects consumed the glucose sample in 5-10 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

Glucose Ref - Std
Glucose Ref and 450 ml waterOTHER

First, fasting blood glucose was measured. Then, subjects consumed the glucose sample in 5-10 minutes. Subjects given additional 150 ml water at 45, 75, and 105 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120

Glucose Ref and 450 ml water
White Bread with 250 ml waterOTHER

First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

White Bread with 250 ml water
White Bread and 700 ml waterOTHER

Sample consumed with 250 ml water immediately after meal consumption, and additional 150 ml water at 45, 75, and 105 minutes. First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

White Bread and 700 ml water
White Bread with 125 ml water (twice)OTHER

Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'

White Bread with 125 ml water (twice)

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

Study Sites (1)

PT Nutrifood Indonesia

Jakarta, DKI Jakarta, 13920, Indonesia

RECRUITING

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

    BACKGROUND

  • 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: 2759361BACKGROUND

  • 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: 2203255BACKGROUND

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Vanessa Yolanda, SSi

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR

  • Astri Kurniati, MAppSc

    Nutrifood Research Center

    STUDY CHAIR

  • Lina Antono, MSc

    Nutrifood Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Yolanda, SSi

CONTACT

vanessa.yolanda@nutrifood.co.id

Lina Antono, MSc

CONTACT

lina.antono@nutrifood.co.id

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 9, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

ID(1)