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出境医 / 临床实验 / Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources

Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources

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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia Dietary Supplement: Anthocyanin Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020
Arms and Interventions
Arm Intervention/treatment
No Intervention: White bread
Experimental: Anthocyanin-fortified bread (2% w/w) Dietary Supplement: Anthocyanin
25% w/w anthocyanin extract obtained from black rice
Experimental: Anthocyanin-fortified bread (4% w/w) Dietary Supplement: Anthocyanin
25% w/w anthocyanin extract obtained from black rice
Outcome Measures
Primary Outcome Measures :
  1. Glycemic index [ Time Frame: 2 hours ]
    Change in incremental area-under-curve (min*mmol/L)


Secondary Outcome Measures :
  1. Anthocyanin and metabolite bioavailability [ Time Frame: 0 minutes, 60 minutes, 120 minutes ]
    Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)

  2. Oxidative stress [ Time Frame: 0 minutes, 60 minutes, 120 minutes ]
    Change in total F2-isoprostane concentration (mg/L)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Singapore
Investigational Medicine Unit
Singapore, Singapore, 117599
Sponsors and Collaborators
National University, Singapore
National University Health System, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Mei Hui Liu, PhD National University, Singapore
Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE October 27, 2017
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019) 		Glycemic index [ Time Frame: 2 hours ]
Change in incremental area-under-curve (min*mmol/L)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Anthocyanin and metabolite bioavailability [ Time Frame: 0 minutes, 60 minutes, 120 minutes ]
    Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)
  • Oxidative stress [ Time Frame: 0 minutes, 60 minutes, 120 minutes ]
    Change in total F2-isoprostane concentration (mg/L)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Anthocyanin and metabolite bioavailability [ Time Frame: 0 min, 60 min, 120 min ]
    Change in anthocyanin and anthocyanin metabolite concentrations (mg/L)
  • Oxidative stress [ Time Frame: 0 min, 60 min, 120 min ]
    Change in total F2-isoprostane concentration (mg/L)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
Official Title  ICMJE Glycaemic Index (GI) Evaluation of Carbohydrate-based Food With Functional Ingredients Derived From Food Sources
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Postprandial Hyperglycemia
Intervention  ICMJE Dietary Supplement: Anthocyanin
25% w/w anthocyanin extract obtained from black rice
Study Arms  ICMJE
  • No Intervention: White bread
  • Experimental: Anthocyanin-fortified bread (2% w/w)
    Intervention: Dietary Supplement: Anthocyanin
  • Experimental: Anthocyanin-fortified bread (4% w/w)
    Intervention: Dietary Supplement: Anthocyanin
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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 14, 2019) 		24
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989674
Other Study ID Numbers  ICMJE H-17-064
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mei Hui Liu, National University, Singapore
Study Sponsor  ICMJE National University, Singapore
Collaborators  ICMJE National University Health System, Singapore
Investigators  ICMJE
Principal Investigator: Mei Hui Liu, PhD National University, Singapore
PRS Account National University, Singapore
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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