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CompletedNCT03989674Updated Nov 15, 2024

Glycaemic Index (GI) Evaluation of Carbohydrate-based Food with Functional Ingredients Derived from Food Sources

An interventional study of Anthocyanin in Postprandial Hyperglycemia, sponsored by National University of Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by National University of Singapore · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2017, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

In Singapore, the Ministry of Health has declared a "War on Diabetes" and major efforts will be made to develop and deploy programs to prevent diabetes. One of the cornerstones of diabetes management involves dietary modifications to reduce postprandial hyperglycaemia. However, implementation of a low GI diet is highly complex requiring the individual to choose foods from a long list which are primarily based on western consumption patterns. Many foods in the Asian diet, which largely consist of carbohydrates such as white rice, noodles and other flour based products, are not represented. An alternative solution will require innovative ways to alter commonly available food products that will not only help reduce postprandial glycaemia but also preserve the sensory characteristics of the foods to create a new generation of food products both functional and palatable. One such approach is the incorporation of plant compounds that lower the glucose absorption from foods. The aim of the project is to measure the GI of carbohydrate-based food with edible plant derived molecules. Natural, plant-derived anthocyanin will be incorporated into bread to produce low GI bread. Anthocyanins are well known for its anti-oxidant activity and recent studies reported that anthocyanins also had an inhibitory activity against digestive enzymes that break down carbohydrates. It can potentially inhibit amylase, and suppress the increase in postprandial glucose level from starch. Bread is a carbohydrate-rich product, which contains a high amount of rapidly digestible starch, and therefore many of them have a high GI. This study aims to determine the glycaemic effects of anthocyanin fortified bread. The effort is designed to enable and inform population interventions that will have an impact on the health of the population in a sustainable manner by introducing innovative foods into the food supply that are 'health promoting' based on rigorous human experiments and are acceptable to the public and other major stakeholders.

02

Conditions studied

  • Postprandial Hyperglycemia

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Keywords

  • Glycemic index
  • Postprandial hyperglycemia
  • Anthocyanin
  • Black rice
03

In context

Hyperglycemia

701 studies on the registry are indexed under Hyperglycemia; 107 are open to participants now.

This study's enrollment of 24 is below the median of 45 across 523 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

National University of Singapore is the lead sponsor of 206 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ability to give informed consent
  • Age between 21-65 years old
  • Overtly healthy males or females, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the performance of the biomarker panel, will not place the subject at increased risk by participating in the study, and will not interfere with interpretation of the data.
  • Not on any regular medications (western / traditional medicine). Nutritional supplements with established chemical composition that can be ascertained and clearly recorded is acceptable.

However, subjects using traditional medicine (with compositions that cannot be ascertained) will be excluded in this study.

  • Have venous access sufficient to allow for blood sampling as per the protocol
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures (participants are required to fast overnight for 10-12h before each visit).

Exclusion criteria

Exclusion Criteria:

  • History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data
  • Known or ongoing psychiatric disorders within 3 years
  • Regularly use known drugs of abuse within 3 years
  • Women who are pregnant or lactating
  • Have donated blood of more than 500 mL within 4 weeks of study enrolment
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females):

    • 1 unit = 12 oz or 360 mL of beer;
    • 5 oz or 150 mL of wine;
    • 1.5 oz or 45 mL of distilled spirits
  • Uncontrolled hypertension (blood pressure [BP] >160/100mmHg
  • Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1
  • Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study
  • Known allergy to insulin
  • History of bleeding diathesis or coagulopathy
  • Any of the following laboratory values at screening:

Fasting glucose >=126mg/dL(>=7mmol/L) or 2 hour post-prandial glucose >=200mg/dL (>=11.1mmol/L)

  • Clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the patient or interfere with data integrity
  • Have any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
  • Significant change in weight (+/- 5%) during the past month
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • No intervention
    White bread
  • Experimental
    Anthocyanin-fortified bread (2% w/w)

    Dietary Supplement: Anthocyanin

  • Experimental
    Anthocyanin-fortified bread (4% w/w)

    Dietary Supplement: Anthocyanin

Interventions

  • Dietary supplementAnthocyanin

    25% w/w anthocyanin extract obtained from black rice

06

What researchers measure

Primary outcomes

  1. Glycemic index

    Change in incremental area-under-curve (min\*mmol/L)

    Time frame: 2 hours

Secondary outcomes

  1. Anthocyanin and metabolite bioavailability

    Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)

    Time frame: 0 minutes, 60 minutes, 120 minutes

  2. Oxidative stress

    Change in total F2-isoprostane concentration (mg/L)

    Time frame: 0 minutes, 60 minutes, 120 minutes

07

Study locations

1 site
  • Investigational Medicine Unit
    Singapore, 117599, Singapore
08

References and documents

Publications

  • Sui X, Zhang Y, Zhou W. Bread fortified with anthocyanin-rich extract from black rice as nutraceutical sources: Its quality attributes and in vitro digestibility. Food Chem. 2016 Apr 1;196:910-6. doi: 10.1016/j.foodchem.2015.09.113. Epub 2015 Oct 9. PubMed 26593572 ↗
  • van Dam RM, Naidoo N, Landberg R. Dietary flavonoids and the development of type 2 diabetes and cardiovascular diseases: review of recent findings. Curr Opin Lipidol. 2013 Feb;24(1):25-33. doi: 10.1097/MOL.0b013e32835bcdff. PubMed 23254472 ↗
  • Zhang PW, Chen FX, Li D, Ling WH, Guo HH. A CONSORT-compliant, randomized, double-blind, placebo-controlled pilot trial of purified anthocyanin in patients with nonalcoholic fatty liver disease. Medicine (Baltimore). 2015 May;94(20):e758. doi: 10.1097/MD.0000000000000758. PubMed 25997043 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03989674
Lead sponsor
National University of Singapore
Collaborators
National University Health System, Singapore
Responsible party
Mei Hui Liu (Senior Lecturer, National University of Singapore) — Principal investigator
First posted
Jun 18, 2019
Start date
Oct 27, 2017
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018
Last update
Nov 15, 2024

Study contacts

Mei Hui Liu, PhD
principal investigator · National University of Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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