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

Primary Purpose

Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Control
Cumin Rice
Cumin Drink
Cornsilk Rice (Low dose)
Cornsilk Rice (High dose)
Cornsilk Drink (Low dose)
Cornsilk Drink (High dose)
Tamarind Rice
Tamarind Drink
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Disease

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Cumin Rice

Cumin Drink

Cornsilk Rice (Low dose)

Cornsilk Rice (High dose)

Cornsilk Drink (Low dose)

Cornsilk Drink (High dose)

Tamarind Rice

Tamarind Drink

Arm Description

50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas.

50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas.

50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas.

50 grams carbohydrate in the form of rice with cornsilk extract (low dose), 200 milliliters of plain water and 20 grams of garden peas.

50 grams carbohydrate in the form of rice with cornsilk extract (high dose), 200 milliliters of plain water and 20 grams of garden peas.

50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (low dose) in solution and 20 grams of garden peas.

50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (high dose) in solution and 20 grams of garden peas.

50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas.

50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas.

Outcomes

Primary Outcome Measures

Glucose
Plasma glucose measured by COBAS

Secondary Outcome Measures

Diastolic and Systolic Blood Pressure
Diastolic and Systolic Blood pressure measured by automated blood pressure monitor
Insulin
Plasma Insulin measured by COBAS

Full Information

First Posted
September 25, 2018
Last Updated
February 1, 2021
Sponsor
Clinical Nutrition Research Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03685916
Brief Title
Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
Acronym
PRIFF
Official Title
Screening of Phytochemical Rich Ingredients as 'Functional Foods' to Improve Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
50 grams carbohydrate in the form of rice, 200 milliliters of plain water and 20 grams of garden peas.
Arm Title
Cumin Rice
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice with cumin, 200 milliliters of plain water and 20 grams of garden peas.
Arm Title
Cumin Drink
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice, 200 milliliters of cumin extract in solution and 20 grams of garden peas.
Arm Title
Cornsilk Rice (Low dose)
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice with cornsilk extract (low dose), 200 milliliters of plain water and 20 grams of garden peas.
Arm Title
Cornsilk Rice (High dose)
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice with cornsilk extract (high dose), 200 milliliters of plain water and 20 grams of garden peas.
Arm Title
Cornsilk Drink (Low dose)
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (low dose) in solution and 20 grams of garden peas.
Arm Title
Cornsilk Drink (High dose)
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice, 200 milliliters of cornsilk extract (high dose) in solution and 20 grams of garden peas.
Arm Title
Tamarind Rice
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice with Tamarind, 200 milliliters of plain water and 20 grams of garden peas.
Arm Title
Tamarind Drink
Arm Type
Experimental
Arm Description
50 grams carbohydrate in the form of rice, 200 milliliters of Tamarind extract in solution and 20 grams of garden peas.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Plain rice with plain water
Intervention Type
Other
Intervention Name(s)
Cumin Rice
Intervention Description
Cumin rice with plain water
Intervention Type
Other
Intervention Name(s)
Cumin Drink
Intervention Description
Cumin drink with plain rice
Intervention Type
Other
Intervention Name(s)
Cornsilk Rice (Low dose)
Intervention Description
Low dose cornsilk rice with plain water
Intervention Type
Other
Intervention Name(s)
Cornsilk Rice (High dose)
Intervention Description
High dose cornsilk rice with plain water
Intervention Type
Other
Intervention Name(s)
Cornsilk Drink (Low dose)
Intervention Description
Low dose cornsilk drink with plain rice
Intervention Type
Other
Intervention Name(s)
Cornsilk Drink (High dose)
Intervention Description
High dose cornsilk drink with plain rice
Intervention Type
Other
Intervention Name(s)
Tamarind Rice
Intervention Description
Tamarind rice with plain water
Intervention Type
Other
Intervention Name(s)
Tamarind Drink
Intervention Description
Tamarind drink with plain rice
Primary Outcome Measure Information:
Title
Glucose
Description
Plasma glucose measured by COBAS
Time Frame
Up to 180 minutes
Secondary Outcome Measure Information:
Title
Diastolic and Systolic Blood Pressure
Description
Diastolic and Systolic Blood pressure measured by automated blood pressure monitor
Time Frame
Up to 180 minutes
Title
Insulin
Description
Plasma Insulin measured by COBAS
Time Frame
Up to 180 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy male participants
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

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

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