Status:
COMPLETED
Black Rice Anthocyanin in Mixed Meals: Influence on Postprandial Glycaemic and Lipid Responses Among Healthy Individuals
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
National University Health System, Singapore
Conditions:
Postprandial Hyperglycemia
Lipidemia
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The diabetes epidemic is a pertinent concern globally. The prevalence of this metabolic disease among adults had been disclosed by the World health Organisation (WHO), reporting a total of 422 million...
Detailed Description
Black rice anthocyanin-fortified bread, compared to white bread as a control, is hypothesised to improve glycaemic control and serum lipid profiles in a mixed meal setting. The aim of this research is...
Eligibility Criteria
Inclusion
- Ability to give informed consent.
- Age between 21 - 65 years old.
- Healthy Body Mass Index (BMI) range of
- males: \>=18.5 kg/m2 and \<=24.9 kg/m2,
- females: \>=18.5 kg/m2 and \<=22.9 kg/m2.
- 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 sufficient venous access 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.
- No dietary restriction to beef intake.
Exclusion
- Persons with a 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.
- Persons with electronic medical implants (e.g. pacemaker).
- Persons with known or ongoing psychiatric disorders within 3 years.
- Persons with regular use of known drugs of abuse within 3 years.
- Women who are pregnant or lactating.
- Persons who have donated more than 500 mL of blood 4 weeks prior to study enrolment.
- Persons with an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females). 1 unit is equivalent to:
- 12 oz or 360 mL of beer;
- 5 oz or 150 mL of wine;
- 5 oz or 45 mL of distilled spirits.
- Persons with uncontrolled hypertension (i.e. blood pressure \>160/100 mmHg)
- Persons with active infection(s) requiring systemic, antiviral or antimicrobial therapy that will not be completed prior to the first study visit.
- Persons who have undergone treatment with any investigational drug or biological agent within one (1) month of screening, or plans to enrol in another study involving investigational drugs/ biological agents during the duration of this study.
- Persons with a known allergy to insulin.
- Persons with a history of bleeding diathesis or coagulopathy.
- Persons with fasting glucose of \>=126 mg/dL (\>=7 mmol/L) or 2-hour postprandial glucose of \>=200 mg/dL (\>=11.1 mol/L).
- Persons with clinically significant (as determined by investigator) abnormalities on laboratory examination that will increase risk to the subject or interfere with data integrity.
- Persons with 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.
- Persons with significant change in weight (+/- 5%) during the past month.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04063137
Start Date
September 16 2019
End Date
December 30 2020
Last Update
November 15 2024
Active Locations (1)
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1
National University of Singapore
Singapore, Singapore