Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03685916 |
| Other study ID # |
2018/00258 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2018 |
| Est. completion date |
September 15, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Clinical Nutrition Research Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
