Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
PRIFF
1 other identifier
interventional
20
1 country
1
Brief Summary
To find out whether consumption of different kinds of plant based functional food ingredients, traditionally used in Asia, can improve post-meal response of indicators of heart and metabolic (cardiometabolic) function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2018
CompletedFirst Submitted
Initial submission to the registry
September 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedFebruary 3, 2021
February 1, 2021
2.4 years
September 25, 2018
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose
Plasma glucose measured by COBAS
Up to 180 minutes
Secondary Outcomes (2)
Diastolic and Systolic Blood Pressure
Up to 180 minutes
Insulin
Up to 180 minutes
Study Arms (9)
Control
OTHER50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas.
Cumin Rice
EXPERIMENTAL50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas.
Cumin Drink
EXPERIMENTAL50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas.
Cornsilk Rice (Low dose)
EXPERIMENTAL50 grams carbohydrate in the form of rice with cornsilk extract (low dose), 200 milliliters of plain water and 20 grams of garden peas.
Cornsilk Rice (High dose)
EXPERIMENTAL50 grams carbohydrate in the form of rice with cornsilk extract (high dose), 200 milliliters of plain water and 20 grams of garden peas.
Cornsilk Drink (Low dose)
EXPERIMENTAL50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (low dose) in solution and 20 grams of garden peas.
Cornsilk Drink (High dose)
EXPERIMENTAL50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (high dose) in solution and 20 grams of garden peas.
Tamarind Rice
EXPERIMENTAL50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas.
Tamarind Drink
EXPERIMENTAL50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas.
Interventions
Eligibility Criteria
You may qualify if:
- Chinese Male
- Age between 21 to 60 years
- Body Mass Index between 18.5 to 25.0 kg/m2
- Waist circumference ≤ 90cm
- Fasting blood glucose \< 7.0mmol/L
- Blood pressure \<140mmHg systolic and \< 90mmHg diastolic
- Do not partake in sports at the competitive and/or endurance levels and willing to stop any strenuous activity during or within 24 hours of test days
You may not qualify if:
- Smoking
- Allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
- Anyone with intentional food restrictions
- People with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
- Having metabolic or cardiovascular diseases (such as diabetes, hypertension, heart condition, etc), Having any other diseases involving the small intestine or the colon (e.g., irritable bowel syndrome, inflammatory bowel disease, gastric reflux) or having any liver or kidney disorders or any family history of kidney stones.
- Having medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics),
- Taking any prescribed medication or dietary supplements which may interfere with the study measurements
- Excessive alcohol consumption: consuming ≥ 6 alcoholic drinks per week
- Individuals who have donated blood or taken part in other studies within 4 weeks of study participation.
- Have poor veins impeding venous access
- Have history of severe vasovagal syncope (blackouts or near faints) following blood draws
- Have known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Have active Tuberculosis (TB) or currently receiving treatment for TB
- A team member of the study or is an immediate family member (Immediate family defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Centre
Singapore, 117599, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 25, 2018
First Posted
September 26, 2018
Study Start
April 25, 2018
Primary Completion
September 15, 2020
Study Completion
September 15, 2020
Last Updated
February 3, 2021
Record last verified: 2021-02