Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Anthocyanin
Sponsored by
About this trial
This is an interventional supportive care trial for Postprandial Hyperglycemia focused on measuring Glycemic index, Postprandial hyperglycemia, Anthocyanin, Black rice
Eligibility Criteria
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:
- 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
Sites / Locations
- Investigational Medicine Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
White bread
Anthocyanin-fortified bread (2% w/w)
Anthocyanin-fortified bread (4% w/w)
Arm Description
Outcomes
Primary Outcome Measures
Glycemic index
Change in incremental area-under-curve (min*mmol/L)
Secondary Outcome Measures
Anthocyanin and metabolite bioavailability
Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)
Oxidative stress
Change in total F2-isoprostane concentration (mg/L)
Full Information
NCT ID
NCT03989674
First Posted
June 14, 2019
Last Updated
July 23, 2021
Sponsor
National University of Singapore
Collaborators
National University Health System, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03989674
Brief Title
Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Official Title
Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
National University Health System, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
Glycemic index, Postprandial hyperglycemia, Anthocyanin, Black rice
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White bread
Arm Type
No Intervention
Arm Title
Anthocyanin-fortified bread (2% w/w)
Arm Type
Experimental
Arm Title
Anthocyanin-fortified bread (4% w/w)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Anthocyanin
Intervention Description
25% w/w anthocyanin extract obtained from black rice
Primary Outcome Measure Information:
Title
Glycemic index
Description
Change in incremental area-under-curve (min*mmol/L)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Anthocyanin and metabolite bioavailability
Description
Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)
Time Frame
0 minutes, 60 minutes, 120 minutes
Title
Oxidative stress
Description
Change in total F2-isoprostane concentration (mg/L)
Time Frame
0 minutes, 60 minutes, 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Hui Liu, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Medicine Unit
City
Singapore
ZIP/Postal Code
117599
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26593572
Citation
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.
Results Reference
background
PubMed Identifier
23254472
Citation
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.
Results Reference
background
PubMed Identifier
25997043
Citation
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.
Results Reference
background
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Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
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