Metabolic DiseasePRIFFNCT03685916
Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
A study testing Cumin Rice, Cumin Drink and Cornsilk Rice (Low dose) in people with Metabolic Disease, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- Cumin Rice, Cumin Drink and Cornsilk Rice (Low dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Apr 2018to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study will be a non-blinded, randomised crossover trial with each participants testing between 2 to 4 different test ingredients requiring 5 or 9 separate test sessions (depending on how many the participants opt in for) on 9 non-consecutive days. The number of test ingredients that each participant will consume will be determined by the researcher and communicated to the participant. One of the test sessions will be a control session consisting of plain white rice (50 g available carbohydrates), with 20 g green vegetables being consumed with 200 ml of plain water. On the other hand, the test meal ingredients will be added either to the same amount of rice during preparation or will be added to 200 ml of plain water. The participants will be required to finish the meals within 15 minutes of serving. Appropriate food safety guidelines will be adhered to during the preparation and administration of test meals. We will be testing 20 separate food based traditional ingredients at either one or two doses. 20 participants will be recruited for each test food. Assuming that a minimum 2 test ingredients are tested in each participant up to 200 Chinese male participants aged between 21 and 60 years will be recruited from the general public in Singapore with body mass index between18.5 to 25.0 kg/m2, normal blood pressure (<140/90 mmHg), and fasting blood glucose (<7.0 mmol/L). The exclusion criteria are people who smoke, with any metabolic diseases (such as diabetes, hypertension etc), with glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency), with medical conditions and/ or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics), intolerances or allergies to any foods, partake in sports at the competitive and/or endurance levels and individual who intentionally restrict food intake. Interested participants will first attend a consent and screening visit following an overnight fast to go over the informed consent procedure and ascertain their suitability to take part in the study. During this visit, the researchers will discuss the study in more detail and go through the participant information sheet and address any queries that the potential participant may have. If participants are willing to proceed, they will then be asked to sign the informed consent form and complete the screening visit forms and questionnaires. If suitable to proceed, they will then undertake the screening visit measurements including height, weight, waist circumference, body impedance and blood pressure measurements. If suitable at this stage, a finger prick blood glucose measurement will be carried out using the HemoCue® device (Helsingborg, Sweden). The visit should last approximately 1.5 hours. During each of the test days, participants will receive test meals in a random order made with up to 4 different food based test ingredients or the control meal (without any test ingredients). Randomisation of test meals will be done using the =RAND() function in Excel. The ingredients will tested in various doses and/or forms of consumption. The participants will arrive at the study centre following an overnight fast. After a 15 minute rest period, they will have a cannula inserted in their arm to obtain blood samples at regular intervals. There will be 9 blood draws in total per test session: Baseline (0 h, before test meal) and 8 blood samples after test meals at 0.25 h, 0.5 h, 0.75 h, 1.0 h, 1.5 h, 2.0 h, 2.5 h and 3.0 h. At each time point, we will collect 3 ml (about half a teaspoon) of blood. Therefore, for each test day, up to 30 ml blood will be taken and for the entire 9 test sessions, around 270 ml of blood will be collected (around 18 tablespoons) or if the participants only opt in for 5 test sessions, they will donate approximately 150 ml of blood (around 10 tablespoons). The blood samples collected at each timepoint will be measured for glucose, insulin and markers related to the intake of the test meal ingredients. At 4 time points (0 h, 1 h, 2 h and 3 h), seated blood pressure measurements will also be undertaken for 3 times, using an automated sphygmomanometer (Omron, Japan) and the average of the final two blood pressure readings will be taken as that given timepoint. Each test day should take no longer than 4 hours to complete. Participants will be asked to refrain from alcohol and exercise the day before each test day. The study will last between 4 and 12 weeks to compete and each test session will be undertaken on non- consecutive days, dependent on the participants' availability. The participants will be asked to continue with their usual lifestyle during their study participation when they are not attending the test sessions.
- Conditions
- Metabolic Disease
- Being tested
- Control, Cumin Rice, Cumin Drink, Cornsilk Rice (Low dose), Cornsilk Rice (High dose)
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Plain rice with plain water
Cumin RiceOther
Cumin rice with plain water
Cumin DrinkOther
Cumin drink with plain rice
Cornsilk Rice (Low dose)Other
Low dose cornsilk rice with plain water
Cornsilk Rice (High dose)Other
High dose cornsilk rice with plain water
Cornsilk Drink (Low dose)Other
Low dose cornsilk drink with plain rice
Cornsilk Drink (High dose)Other
High dose cornsilk drink with plain rice
Tamarind RiceOther
Tamarind rice with plain water
Tamarind DrinkOther
Tamarind drink with plain rice
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | 50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas. Receives: Other: Control |
| Cumin Rice | Experimental | 50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas. Receives: Other: Cumin Rice |
| Cumin Drink | Experimental | 50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas. Receives: Other: Cumin Drink |
| Cornsilk Rice (Low dose) | Experimental | 50 grams carbohydrate in the form of rice with cornsilk extract (low dose), 200 milliliters of plain water and 20 grams of garden peas. Receives: Other: Cornsilk Rice (Low dose) |
| Cornsilk Rice (High dose) | Experimental | 50 grams carbohydrate in the form of rice with cornsilk extract (high dose), 200 milliliters of plain water and 20 grams of garden peas. Receives: Other: Cornsilk Rice (High dose) |
| Cornsilk Drink (Low dose) | Experimental | 50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (low dose) in solution and 20 grams of garden peas. Receives: Other: Cornsilk Drink (Low dose) |
| Cornsilk Drink (High dose) | Experimental | 50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (high dose) in solution and 20 grams of garden peas. Receives: Other: Cornsilk Drink (High dose) |
| Tamarind Rice | Experimental | 50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas. Receives: Other: Tamarind Rice |
| Tamarind Drink | Experimental | 50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas. Receives: Other: Tamarind Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Plasma glucose measured by COBAS
Measured: Up to 180 minutes
Secondary outcomes (2)
Diastolic and Systolic Blood Pressure
Diastolic and Systolic Blood pressure measured by automated blood pressure monitor
Measured: Up to 180 minutes
Insulin
Plasma Insulin measured by COBAS
Measured: Up to 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start25 Apr 2018
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685916
- Sponsor's protocol ID
- 2018/00258
- Other IDs
- 2018
- Acronym
- PRIFF
- Status last verified
- Feb 2021
- First submitted
- 25 Sep 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03685916
- Acronym / sponsor ID
- PRIFF / 2018/00258
- Conditions
- Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be a non-blinded, randomised crossover trial with each participants testing between 2 to 4 different test ingredients requiring 5 or 9 separate test sessions (depending on how many the participants opt in for) on 9 non-consecutive days. The number of test ingredients that each participant will consume will be determined by the researcher and communicated to the participant. One of the test sessions will be a control session consisting of plain white rice (50 g available carbohydrates), with 20 g green vegetables being consumed with 200 ml of plain water. On the other hand, the test meal ingredients will be added either to the same amount of rice during preparation or will be added to 200 ml of plain water. The participants will be required to finish the meals within 15 minutes of serving. Appropriate food safety guidelines will be adhered to during the preparation and administration of test meals. We will be testing 20 separate food based traditional ingredients at either one or two doses. 20 participants will be recruited for each test food. Assuming that a minimum 2 test ingredients are tested in each participant up to 200 Chinese male participants aged between 21 and 60 years will be recruited from the general public in Singapore with body mass index between18.5 to 25.0 kg/m2, normal blood pressure (<140/90 mmHg), and fasting blood glucose (<7.0 mmol/L). The exclusion criteria are people who smoke, with any metabolic diseases (such as diabetes, hypertension etc), with glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency), with medical conditions and/ or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics), intolerances or allergies to any foods, partake in sports at the competitive and/or endurance levels and individual who intentionally restrict food intake. Interested participants will first attend a consent and screening visit following an overnight fast to go over the informed consent procedure and ascertain their suitability to take part in the study. During this visit, the researchers will discuss the study in more detail and go through the participant information sheet and address any queries that the potential participant may have. If participants are willing to proceed, they will then be asked to sign the informed consent form and complete the screening visit forms and questionnaires. If suitable to proceed, they will then undertake the screening visit measurements including height, weight, waist circumference, body impedance and blood pressure measurements. If suitable at this stage, a finger prick blood glucose measurement will be carried out using the HemoCue® device (Helsingborg, Sweden). The visit should last approximately 1.5 hours. During each of the test days, participants will receive test meals in a random order made with up to 4 different food based test ingredients or the control meal (without any test ingredients). Randomisation of test meals will be done using the =RAND() function in Excel. The ingredients will tested in various doses and/or forms of consumption. The participants will arrive at the study centre following an overnight fast. After a 15 minute rest period, they will have a cannula inserted in their arm to obtain blood samples at regular intervals. There will be 9 blood draws in total per test session: Baseline (0 h, before test meal) and 8 blood samples after test meals at 0.25 h, 0.5 h, 0.75 h, 1.0 h, 1.5 h, 2.0 h, 2.5 h and 3.0 h. At each time point, we will collect 3 ml (about half a teaspoon) of blood. Therefore, for each test day, up to 30 ml blood will be taken and for the entire 9 test sessions, around 270 ml of blood will be collected (around 18 tablespoons) or if the participants only opt in for 5 test sessions, they will donate approximately 150 ml of blood (around 10 tablespoons). The blood samples collected at each timepoint will be measured for glucose, insulin and markers related to the intake of the test meal ingredients. At 4 time points (0 h, 1 h, 2 h and 3 h), seated blood pressure measurements will also be undertaken for 3 times, using an automated sphygmomanometer (Omron, Japan) and the average of the final two blood pressure readings will be taken as that given timepoint. Each test day should take no longer than 4 hours to complete. Participants will be asked to refrain from alcohol and exercise the day before each test day. The study will last between 4 and 12 weeks to compete and each test session will be undertaken on non- consecutive days, dependent on the participants' availability. The participants will be asked to continue with their usual lifestyle during their study participation when they are not attending the test sessions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Control50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas. |
| Cumin Rice | Experimental | Other: Cumin Rice50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas. |
| Cumin Drink | Experimental | Other: Cumin Drink50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas. |
| Cornsilk Rice (Low dose) | Experimental | Other: Cornsilk Rice (Low dose)50 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) | Experimental | Other: Cornsilk Rice (High dose)50 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) | Experimental | Other: Cornsilk Drink (Low dose)50 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) | Experimental | Other: Cornsilk Drink (High dose)50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (high dose) in solution and 20 grams of garden peas. |
| Tamarind Rice | Experimental | Other: Tamarind Rice50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas. |
| Tamarind Drink | Experimental | Other: Tamarind Drink50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlPlain rice with plain water | Other | Control |
| Cumin RiceCumin rice with plain water | Other | Cumin Rice |
| Cumin DrinkCumin drink with plain rice | Other | Cumin Drink |
| Cornsilk Rice (Low dose)Low dose cornsilk rice with plain water | Other | Cornsilk Rice (Low dose) |
| Cornsilk Rice (High dose)High dose cornsilk rice with plain water | Other | Cornsilk Rice (High dose) |
| Cornsilk Drink (Low dose)Low dose cornsilk drink with plain rice | Other | Cornsilk Drink (Low dose) |
| Cornsilk Drink (High dose)High dose cornsilk drink with plain rice | Other | Cornsilk Drink (High dose) |
| Tamarind RiceTamarind rice with plain water | Other | Tamarind Rice |
| Tamarind DrinkTamarind drink with plain rice | Other | Tamarind Drink |
Primary outcome
Glucose
Time frame: Up to 180 minutes
Plasma glucose measured by COBAS
2 secondary outcomes
Diastolic and Systolic Blood Pressure
Time frame: Up to 180 minutes
Insulin
Time frame: Up to 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cumin Rice, Cumin Drink and Cornsilk Rice (Low dose) in people with Metabolic Disease, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: Up to 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.