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.
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.
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.
- Conditions
- Pre Diabetes, Diabetes, Obesity
- 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 group | Role | What they receive |
|---|---|---|
| Control 1 | Other | Glucose 25g Receives: Other: Control 1 |
| Control 2 | Other | Glucose 25g Receives: Other: Control 2 |
| Standard Crokao | Experimental | Commercially available snack bar Receives: Other: Standard Crokao |
| Low sugar variant 1 | Experimental | Low sugar snack bar with sticky rice Receives: Other: Low sugar variant 1 |
| Low sugar variant 2 | Experimental | Low sugar snack bar with promitor Receives: Other: Low sugar variant 2 |
| Low sugar variant 3 | Experimental | Low sugar snack bar with inulin Receives: Other: Low sugar variant 3 |
| Low sugar variant 4 | Experimental | Low sugar snack bar with yellow soy Receives: Other: Low sugar variant 4 |
| Low sugar variant 5 | Experimental | Low 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.
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)
Change in postprandial plasma insulin over 240 minutes period
Venous blood obtain through cannula, analysed using Beckman Coulter analyser.
Measured: 240 minutes
Change in postprandial plasma triglycerides over 240 minutes period
Venous blood obtain through cannula, analysed using Beckman Coulter analyser.
Measured: 240 minutes
Change in postprandial plasma non esterified fatty acids over 240 minutes period
Venous blood obtain through cannula, analysed using chemistry analyser.
Measured: 240 minutes
Change in postprandial plasma active ghrelin over 240 minutes period
Venous blood obtain through cannula, analysed using ELISA analyser.
Measured: 240 minutes
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.
- First posted4 Dec 2020
- Study start13 Nov 2019
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response Evaluation of Low-sugar Snack Bars
- ClinicalTrials.gov ID
- NCT04653220
- Acronym / sponsor ID
- 2019/00861
- Conditions
- Pre Diabetes, Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Randomized crossover study
| Arm | Type | Receives |
|---|---|---|
| Control 1 | Other | Other: Control 1Glucose 25g |
| Control 2 | Other | Other: Control 2Glucose 25g |
| Standard Crokao | Experimental | Other: Standard CrokaoCommercially available snack bar |
| Low sugar variant 1 | Experimental | Other: Low sugar variant 1Low sugar snack bar with sticky rice |
| Low sugar variant 2 | Experimental | Other: Low sugar variant 2Low sugar snack bar with promitor |
| Low sugar variant 3 | Experimental | Other: Low sugar variant 3Low sugar snack bar with inulin |
| Low sugar variant 4 | Experimental | Other: Low sugar variant 4Low sugar snack bar with yellow soy |
| Low sugar variant 5 | Experimental | Other: Low sugar variant 5Low sugar snack bar with rice syrup |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control 125g glucose dissolve in 250ml of water | Other | Control 1 |
| Control 225g glucose dissolve in 250ml of water | Other | Control 2 |
| Standard CrokaoStandard Crokao containing 25g of available carbohydrate | Other | Standard Crokao |
| Low sugar variant 1Low sugar variant 1 containing 25g of available carbohydrate | Other | Low sugar variant 1 |
| Low sugar variant 2Low sugar variant 2 containing 25g of available carbohydrate | Other | Low sugar variant 2 |
| Low sugar variant 3Low sugar variant 3 containing 25g of available carbohydrate | Other | Low sugar variant 3 |
| Low sugar variant 4Low sugar variant 4 containing 25g of available carbohydrate | Other | Low sugar variant 4 |
| Low sugar variant 5Low sugar variant 5 containing 25g of available carbohydrate | Other | Low sugar variant 5 |
Primary outcome
Change in postprandial blood glucose over 240 minutes period
Time frame: 240 minutes
Venous Blood obtained through canula, analysed using Beckman Coulter analyser.
5 secondary outcomes
Change in postprandial plasma insulin over 240 minutes period
Time frame: 240 minutes
Change in postprandial plasma triglycerides over 240 minutes period
Time frame: 240 minutes
Change in postprandial plasma non esterified fatty acids over 240 minutes period
Time frame: 240 minutes
Change in postprandial plasma active ghrelin over 240 minutes period
Time frame: 240 minutes
Change in postprandial plasma active GLP-1 over 240 minutes period
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.