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

NCT04063137 | Completed DMC

• 1 other identifier: 2018/00971
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 diabetic adults and 3.7 million diabetic deaths in 2016, with Asian countries contributing more than 60% of the world's diabetic population. Due to its economic and social repercussions, preventive strategies are implemented at a population level. The implementation of a diet low in glycaemic index (GI) has been widely adopted as part of diabetes management strategies to prevent and control Type 2 Diabetes Mellitus (T2DM) as the consumption of food with low GI has shown to improve glycaemic control, lipid profile, and reduce systemic inflammation. Other strategies include adopting an active lifestyle and the consumption of functional foods. In lieu of this, the composition of food products may be altered by incorporating edible plant-based functional components with carbohydrase-inhibiting properties. Black rice has been proposed as a viable source of functional ingredients, namely anthocyanins, not only because of its potential benefits to health that has been established by numerous in-vitro studies, but also it is easily sourced for in Asia as it is widely cultivated. In this study, black rice anthocyanin-fortified bread serves as a replacement to white bread as the staple to the subject's diet, in a mixed meal setting. The fortified bread is hypothesised to improve glycemic responses over white bread, offering a lower GI food alternative to the conventional staple.

Conditions

Postprandial Hyperglycemia; Lipidemia

Keywords

Black rice; Anthocyanin; Lipidemia; High-fat diet

Outcome Measures

Primary Outcomes (1)

• Change in area under curve for Low-density lipoprotein cholesterol (LDL-c)

  mmol/L\*min; area under curve

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.

Secondary Outcomes (1)

• Change in area under curve for Blood glucose

  0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes.

Study Arms (2)

Anthocyanin fortified bread

ACTIVE COMPARATOR

White bread is fortified with a 25% (w/w) black rice anthocyanin extract. Extract fortification is 4% w/w of bread flour.

Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat)

White bread

PLACEBO COMPARATOR

Dietary Supplement: Anthocyanin fortified bread with beef patty (35% fat)

Interventions

Anthocyanin fortified bread with beef patty (35% fat) DIETARY_SUPPLEMENT

Bread is fortified at a 4% level using 25% (w/w) anthocyanin black rice extract. It is served with a beef patty (35% fat) to simulate a high-fat diet.

Anthocyanin fortified bread; White bread

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• oz or 360 mL of beer;
• oz or 150 mL of wine;
• 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.

Sponsors & Collaborators

• National University of Singapore: lead
• National University Health System, Singapore: collaborator

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Hyperglycemia; Hyperlipidemias

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Platelet Membrane Glycoproteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Fatty Acid Transport Proteins; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Receptors, Cell Surface; Receptors, Immunologic; Scavenger Receptors, Class B; Receptors, Scavenger; Receptors, LDL; Receptors, Lipoprotein

Study Officials

• Mei Hui Liu

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a within-subject cross-over trial design to assess the influence of black rice anthocyanin on postprandial blood glucose and insulinemic responses, and lipid profiles.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: August 21, 2019
• Study Start: September 16, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 15, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)