AzTrials
AzTrials

Pre DiabetesNCT04653220

Metabolic Response Evaluation of Low-sugar Snack Bars

A study testing Standard Crokao, Low sugar variant 1 and Low sugar variant 2 in people with Pre Diabetes and Diabetes, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To determine the post-prandial metabolic response and biomarker response, following the consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are formulated with different combinations and ratios of ingredients and food structures. Read more about this study

Who is it for?
Ages 21 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pre Diabetes, Diabetes, Obesity
What is being tested?
Standard Crokao, Low sugar variant 1 and Low sugar variant 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSingapore
Study dates
13 Nov 2019to 26 May 2023
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male
  • Age between 21-65 years
  • Chinese, Indian and Caucasian Ethnicity
  • Body mass index between 18.5 - 25.5 kg/m2
  • Fasting blood glucose <7.0 mmol/L
  • Normal blood pressure (<140/90 mmHg)
  • In general good health

Who cannot join

  • Smoking
  • Partake in sports at a high competitive and/or endurance levels
  • Intentionally restrict food intakeHave known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Have poor veins impeding venous access and have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
  • Have metabolic diseases (such as diabetes, hypertension, etc.)
  • have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
Show all 12Show fewer
  • Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug,
  • Have any severe food allergy or food intolerance
  • Having active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any 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)
  • Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
  • Concurrent participation in a study that might affect the outcomes of the current study

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Clinical Nutrition Research Centre

    Singapore, 117599

Other trials in Singapore

About this study

To determine the post-prandial metabolic response and biomarker response, following the consumption of newly developed low glycaemic index (GI) snack bars. The snack bars are formulated with different combinations and ratios of ingredients and food structures. The low sugar products maintaining glucose homeostasis and preventing metabolic problems may have commercial potential as a novel functional ingredient in a variety of fields, including nutrition, medicine, and agriculture.

Read the detailed description

In this study we will study and compare the postprandial metabolic response of 5 snack bar variants, 1 control product and 2 glucose (25g) reference drinks. The study will have a total of 8 test sessions in a non-blinded, crossover design. Online computer software will be used for simple randomization of the sequence of the 8 treatments (http://www.randomizer.org/).The 5 snack bars variants will be similar in macronutrient composition but will differ in the source of carbohydrate, fibre and protein (rice, bamboo, inulin, soy, promitor). They will be compared to a visually similar control product (crokao) that is higher in sugar. The reference drink will be anhydrous glucose (25g) dissolved in 250 ml of water.Study population: 15-20 participants will be recruited from each of the following ethnicities: Chinese, Indian and Caucasian. During the screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have with the researcher. The number of test sessions will be discussed between the researcher and the participants, depending on the volunteer's schedule. 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 and subsequently baseline measurements including anthropometric measurements, blood pressure, and fasting blood glucose will be collected from each participant in order to determine their eligibility. The screening questionnaire will include demographic, general health details, and physical activity level. 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 (Tanita scale). Height will be measured using a stadiometer in order to calculate participants' BMI. Waist circumference will be measured at the minimum circumference between the iliac crest and the rib cage and hip circumference will be measured at the maximum protuberance of the buttocks. 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.

Study protocol: The day before a test day, participants will be encouraged to consume their usual diet and avoid alcohol consumption and participating in vigorous exercise. On test days, participants will arrive at the laboratory after an overnight fast of 10 h. Upon arrival, participants will be asked to void, and have their weight and body fat assessed with a Tanita scale. After that, participants will enter the clinical suit and rest for 15 min before a blood catheter is inserted in the antecubital vein of the arm. After the blood catheter is inserted, participants will rest for 15 min, before two baseline blood sample (6 mL) are taken 10 minutes apart (-10 min and 0 min). Immediately after the second sample, participants will be served a test food that has to be consumed within 15 min. Subsequently blood samples (6mL) are obtained at 15, 30, 45, 60, 90,120, 180 and 240min. Appetite sensations (e.g. hunger, fullness, desire-to-eat etc.) will also be measured using questionnaires at similar time points when blood samples are taken. Subjects will be asked to rate their appetite sensations on a 100 mm visual analogue scale (VAS). After each session, the blood catheter will be removed. The participants will leave the laboratory and they will be asked to keep a food diary of what they eat for the remaining day. Participants will return until all test foods are consumed. During the entire test session, the subject will have to stay rested and in the laboratory. Television and a workspace will be provided to the subject.Blood samples will be will analysed for METABOLIC RESPONSE (glucose, insulin, Triglycerides, NEFA, GLP-1 and ghrelin). A 100 uL aliquot of blood during the first blood sample collection (T = -10min) will be obtained from each participant on the first day of treatment (thus only once) for baseline metabolomics profiling.A stool sample from each participant will be obtained to perform the following on the microbiome: DNA extraction, library prep, 16S and shotgun (whole genome) sequencing, and demultiplexing of genomic data. The stool sample will be collected between the screening session and the last test session (time of collection will not influence the sample analysis). The participant will be encouraged to collect the stool sample during one of the sessions at the research centre to eliminate transport of the sample.

Being tested
Control 1, Control 2, Standard Crokao, Low sugar variant 1, Low sugar variant 2
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control 1Other

    25g glucose dissolve in 250ml of water

  • Control 2Other

    25g glucose dissolve in 250ml of water

  • Standard CrokaoOther

    Standard Crokao containing 25g of available carbohydrate

  • Low sugar variant 1Other

    Low sugar variant 1 containing 25g of available carbohydrate

  • Low sugar variant 2Other

    Low sugar variant 2 containing 25g of available carbohydrate

  • Low sugar variant 3Other

    Low sugar variant 3 containing 25g of available carbohydrate

  • Low sugar variant 4Other

    Low sugar variant 4 containing 25g of available carbohydrate

  • Low sugar variant 5Other

    Low sugar variant 5 containing 25g of available carbohydrate

Study groups in NCT04653220
Study groupRoleWhat they receive
Control 1OtherGlucose 25g
Receives: Other: Control 1
Control 2OtherGlucose 25g
Receives: Other: Control 2
Standard CrokaoExperimentalCommercially available snack bar
Receives: Other: Standard Crokao
Low sugar variant 1ExperimentalLow sugar snack bar with sticky rice
Receives: Other: Low sugar variant 1
Low sugar variant 2ExperimentalLow sugar snack bar with promitor
Receives: Other: Low sugar variant 2
Low sugar variant 3ExperimentalLow sugar snack bar with inulin
Receives: Other: Low sugar variant 3
Low sugar variant 4ExperimentalLow sugar snack bar with yellow soy
Receives: Other: Low sugar variant 4
Low sugar variant 5ExperimentalLow sugar snack bar with rice syrup
Receives: Other: Low sugar variant 5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postprandial blood glucose over 240 minutes period

    Venous Blood obtained through canula, analysed using Beckman Coulter analyser.

    Measured: 240 minutes

Secondary outcomes (5)
  1. Change in postprandial plasma insulin over 240 minutes period

    Venous blood obtain through cannula, analysed using Beckman Coulter analyser.

    Measured: 240 minutes

  2. Change in postprandial plasma triglycerides over 240 minutes period

    Venous blood obtain through cannula, analysed using Beckman Coulter analyser.

    Measured: 240 minutes

  3. Change in postprandial plasma non esterified fatty acids over 240 minutes period

    Venous blood obtain through cannula, analysed using chemistry analyser.

    Measured: 240 minutes

  4. Change in postprandial plasma active ghrelin over 240 minutes period

    Venous blood obtain through cannula, analysed using ELISA analyser.

    Measured: 240 minutes

  5. Change in postprandial plasma active GLP-1 over 240 minutes period

    Venous blood obtain through cannula, analysed using ELISA analyser.

    Measured: 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start13 Nov 2019
  3. Primary completion26 May 2023
  4. Study completion26 May 2023

Resources

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
Model description
Randomized crossover study
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653220
Sponsor's protocol ID
2019/00861
Other IDs
2019
Status last verified
Aug 2023
First submitted
27 Nov 2020
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard Crokao, Low sugar variant 1 and Low sugar variant 2 in people with Pre Diabetes and Diabetes, 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 12 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 31 Aug 2023. 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?

Change in postprandial blood glucose over 240 minutes period (time frame: 240 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 31 Aug 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in