Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health (PRIFF)

February 1, 2021 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Control
50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas.
Other: Control
Plain rice with plain water
Experimental: Cumin Rice
50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas.
Other: Cumin Rice
Cumin rice with plain water
Experimental: Cumin Drink
50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas.
Other: Cumin Drink
Cumin drink with plain rice
Experimental: 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.
Other: Cornsilk Rice (Low dose)
Low dose cornsilk rice with plain water
Experimental: 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.
Other: Cornsilk Rice (High dose)
High dose cornsilk rice with plain water
Experimental: 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.
Other: Cornsilk Drink (Low dose)
Low dose cornsilk drink with plain rice
Experimental: 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.
Other: Cornsilk Drink (High dose)
High dose cornsilk drink with plain rice
Experimental: Tamarind Rice
50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas.
Other: Tamarind Rice
Tamarind rice with plain water
Experimental: Tamarind Drink
50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas.
Other: Tamarind Drink
Tamarind drink with plain rice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: Up to 180 minutes
Plasma glucose measured by COBAS
Up to 180 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diastolic and Systolic Blood Pressure
Time Frame: Up to 180 minutes
Diastolic and Systolic Blood pressure measured by automated blood pressure monitor
Up to 180 minutes
Insulin
Time Frame: Up to 180 minutes
Plasma Insulin measured by COBAS
Up to 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/00258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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