Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04115657 |
| Other study ID # |
2018/01194 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2019 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Clinical Nutrition Research Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The first objective is to investigate the effect of boba pearls made from different starches
on glycaemia, insulinaemia and appetite control. The second objective is to investigate the
effects of various sugar blends of sucrose with sugar substitutes in milk tea on glycaemia,
insulinaemia and appetite control.
Description:
Design: There are two parts to this study. Participants will voluntarily choose to
participate in either one or both parts of the study during the first screening session. Part
A: Testing the effects of boba pearls using different starches. Part B: Testing the effects
of milk-based tea with different sugar blends of sucrose with sugar substitutes with a
standard type of boba pearl
Both parts of the study will have a randomized, nonblinded, crossover design. Screening will
occur before the study commences. Participants will be asked to return on four
non-consecutive days (Part A) and two-three non-consecutive days (Part B) with a wash out
period of at least 2 days to avoid crossover effects. In both parts of the study, the test
foods will be consumed with a carbohydrate-based food (for example: bread, biscuit etc.)
Study protocol Screening session: All potential participants will be asked to attend one
screening session to ensure they are eligible to be enrolled into the study. After which,
they will attend either four test sessions (Part A) and/or two-three test sessions (Part B).
If the participant participates in Part A of the study, they will only be required to attend
two test sessions in Part B as they would have completed the control session in Part A. If
participants decide to participate only in Part B of the study, they will have to complete
three test sessions. During the first screening session, participants will receive an
informed consent form and be given ample time to go through it and rectify any queries they
have. If they decide to take part in the study, they will be asked to sign the informed
consent form. They will then be asked to complete a screening questionnaire, baseline
measurements including anthropometric measurements, blood pressure, and fasting blood glucose
will be collected from each participant in order to determine their eligibility. During the
test sessions, participants' glycaemic, insulinaemic and appetite responses to the test meals
will be measured. The test duration for each session will be 4 hours. Participants will be
instructed to avoid strenuous physical activity for at least 3 days and avoid caffeine and
alcohol consumption for at least 1 day prior to visiting the CNRC for their study trials.
Participants will be provided with a standardised dinner meal (consisting of rice/noodles,
vegetables, meat, drink/pudding) and asked to refrain from alcohol and exercise the day
before their testing sessions. Screening questionnaire: The screening questionnaire will
include contact information, demographic and general health details. This information will be
used to determine whether the participant is eligible for the study, as well as to check for
any possible confounders that may influence the study outcomes.
Anthropometric measurements: Body weight and body composition will be measured using
bioelectrical impedance analysis. Height will be measured using a stadiometer in order to
calculate participants' BMI. Blood pressure will also be measured. All measurements will be
taken in duplicate during the screening session. Waist circumference will be measured at the
minimum circumference between the iliac crest and the rib cage. Hip circumference will be
measured at the maximum protuberance of the buttocks. Biceps and triceps skinfold
measurements will also be taken. Blood pressure will be measured using an Omron blood
pressure monitor (Model HEM-907) at baseline. Participants will be seated for five minutes
before blood pressure is measured. Measurements will be taken in duplicate and the averaged
results will be recorded.
Blood collection: Participants will be asked to attend the testing sessions after an
overnight fast of ten hours. After a 15-minute rest period, they will have a cannula inserted
in their arm to obtain blood samples at regular intervals. One fasting blood sample will be
collected by venous cannulation. 3 millilitres (ml) of venous blood will be collected into
Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA for the analyses of
plasma glucose, insulin concentrations. Participants will then consume treatment meal
within15 minutes. Blood samples will be taken at 15, 30, 45, 60, 90, 120, 150 and 180
minutes. The amount of blood that will be collected at every time point will be about 0.6
teaspoon of blood (approximately 3 ml). The accumulative amount per test session will not be
more than 5.4 teaspoons of blood (approximately 27 ml), and the accumulative amount for the
entire study duration will be approximately 108ml of blood for Part A and for Part B, 81ml of
blood (3 test sessions) or 54ml of blood (2 test sessions). The blood samples collected at
each time point will be measured for glucose and insulin. Glycaemic and insulinaemic
responses will be determined using the method described by Wolever and Jenkins. The area
under the curve will be determined as the area of those increments above baseline only.
Metabolic satiety: At the same time intervals, the participants will be instructed to fill in
visual analogue scale (VAS) on feelings of fullness, hunger, desire to eat and prospective
food consumption. VAS are 100 mm continuous lines anchored with opposing answers to a
specific question asked either on a computer or on a hard copy. The specific questions asked
will be, 'How hungry do you feel?', 'How full do you feel?', 'How strong is your desire to
eat?', 'How much more food do you think you can eat?'. The participants will be instructed to
make a mark on the line which corresponds with their subjective feeling. Only for Part A of
the study, upon completion of the blood collection and before lunch, participants will be
asked to drink a mouthful of the bubble tea with pearls (standardised serving size) and to
masticate the boba pearls as they would naturally do. They will be asked to raise their hands
once they swallow the pearls. The researcher would have counted the number of chews (x chews)
to reach the swallow point (when participants raise their hands). Participants will be asked
to rinse their mouth, have the second mouthful and chew x times before expectorating the
bolus for particle size analysis. Three replicates will be collected. Boluses will be placed
in a petri dish and suspended in distilled water to separate the particles before an image is
captured for image analysis. Samples will be discarded upon completion of image analysis.
Test session: Participants will be provided a standard dinner meal to be consumed at home at
7pm the night before the test session on the day of screening for the first session. For
subsequent sessions, all standard dinners will be provided on the last day of each session to
be eaten before the next session. The foods are frozen dinners and can be stored in the
freezer and then reheated to be consumed before the next session. After which, they will be
asked to not eat and drink anything except water after 10:30 pm. They will also be instructed
to arrive at the CNRC the following morning after an overnight fast of 10-12 hours. After 15
minutes upon arrival, an indwelling catheter will be inserted into a vein in your forearm and
will be kept patent (free of clots) for the remainder of the test session. We will then take
a blood sample from the cannula to measure baseline values. After obtaining the baseline
blood samples, participants will be given the test meal to consume within 15 minutes.
Following the test meal, we will take further blood samples (from the cannula) for the next
15, 30, 45, 60, 90, 120, 150 and 180 minutes. Participants will also be asked to complete the
VAS following the same time points from baseline to 180 minutes. After 3 hours, the cannula
will be removed and for Part A of the study, participants will be instructed to masticate
boba pearls and the number of chews to reach swallow point will be recorded. Boluses of the
pearls will be collected and kept for analysis. For both Part A and B, they will then be
asked to consume an ad libitum lunch until they are comfortably full. At the end of the ad
libitum lunch, participants will be asked to complete a final VAS for the measurement of
hunger and feelings of fullness. After which, they are free to leave CNRC. During the entire
testing period the participants will be instructed to remain rested and in the laboratory.
There will be no incidental findings as analysed samples are basic metabolites and therefore,
reporting is not applicable.
