Black Rice Anthocyanin in Mixed Meals: Influence on Postprandial Glycaemic and Lipid Responses Among Healthy Individuals

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring Black rice, Anthocyanin, Lipidemia, High-fat diet Read More

Inclusion Criteria:

• 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 Criteria:

• 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;
  • 1.5 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.