DiabetesNCT02875275
Liquid or Solid State of Food on Glycaemia, Lipaemia and Insulinaemia
A study testing Glucose with grass jelly solution, Glucose with grass jelly (solid) and Porridge and juice with coconut oil in people with Diabetes and Cardiovascular Disease, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Cardiovascular Disease
- What is being tested?
- Glucose with grass jelly solution, Glucose with grass jelly (solid) and Porridge and juice with coconut oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Jan 2016to 27 Jun 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-40 years
- Body Mass Index 18-25 kg/m2
- Body weight more than or equals to 45kg
- Normal blood pressure (≤140/90) and normal fasting blood glucose (<6.0 mM)
Who cannot join
- Have major chronic disease such as heart disease, cancer or diabetes mellitus, intolerances or allergies to test products
- User of insulin or drugs known to affect glucose metabolism and body fat distribution
- People with a major medical or surgical event requiring hospitalization within the preceding 3 months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
- Current smokers
- People who are on any therapeutic diet/drug
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.
Read the detailed description
This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.
Treatments will be randomized to receive 3 different test meals (Oleogel) and/or 3 different test meals. Randomization means assigning the participants to the test meals by chance, like tossing a coin or rolling a dice.
If the participants take part in this study, the participants will be required to come on 3 non-consecutive days and/or 5 non-consecutive days to evaluate the 3 different test meals (Oleogel) and/or 3 different test meal (Grass jelly) respectively, in random order with a minimum of 1 week between the test sessions. For each session, the participants are required to come between 8:00-9:00am, with each session lasting approximately 3.5 hours to 6.5 hours. The participants would have to come following a 10-12 hour overnight fast. An indwelling catheter will be inserted into a vein in the participants' forearm for the remainder of the test session. The investigators will then take a blood sample from the cannula to measure baseline values. The investigators will also take the participant's capillary blood via finger prick to measure blood glucose concentration. After obtaining the baseline blood samples, the investigator will give the participants the test meal to eat within 10 minutes and fill up a 'liking' questionnaire. Following the meal the investigators will take further blood samples (from the cannula and finger pricks) for the next 10, 20, 30, 45, 60, 90, 120, 150, 180, (treatment 4, 5, 6), 210, 240, 270, 300, 330, 360 minutes (Treatment 1, 2, 3).
The amount of blood that will be collected at every time point will be about 5µL droplet from fingerprick and approximately 5mL of blood from cannulation, the accumulative amount per test session will approximately 50 to 80 ml, and the accumulative amount for the entire study duration will be approximately 240 mL of blood by cannula and finger pricks (Part A) and 150 ml (Part B). The investigators will also ask the participants to answer a questionnaire about measurement of hunger and fullness at the same times the blood samples are taken. The appetite-rating questionnaire consists of 100mm continuous lines anchored at each end with opposing statements for a question asked. 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 food do you think you can eat?' and 'Do you have any preoccupation with thoughts of food right now?'. Using a pen, you would have to make a mark on the line corresponding to how you feel.
In addition to the VAS scales, the current trial will collect information on the prospective portion that participants would like to consume for a range of different foods at different time points; at every 30 minutes interval from baseline till the end of each test session. This computer based task presents a range of foods to participants and asks "how much of this food would you like to consume right now?", allowing the participants to move between a series of different portions of each food and select the one that the participants would like to consume at that time based on the participants' feeling of hunger, fullness and desire to eat. The foods will be deliberately chosen to represent common Singaporean meals, desserts and snack foods that are regularly eaten to relieve hunger in different situations and the range of portions available is the same across all foods (20-1200 kcals in 20 kcal steps).
On the evenings before the test sessions, the participants will be expected to come and collect a standard dinner meal. The participants will be advised not to take part in any strenuous physical activities for at least 3 days and avoid caffeine and alcohol consumption the day before the test sessions.
Subjects participation in the study will last a maximum of 20.5 hours (Part A) and 11.5 hours (Part B), include one screening visit lasting around 1 hour.
- Conditions
- Diabetes, Cardiovascular Disease
- Being tested
- Glucose with grass jelly solution, Glucose with grass jelly (solid), Porridge and juice with coconut oil, Porridge and juice with coconut oil gel
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose with grass jelly solutionOther
50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g)
Glucose with grass jelly (solid)Other
50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g)
Porridge and juice with coconut oilOther
Add instant porridge with hot water with oil. Consume with commercially available orange juice
Porridge and juice with coconut oil gelOther
Add instant porridge with hot water with oleogel. Consume with commercially available orange juice
| Study group | Role | What they receive |
|---|---|---|
| Glucose Solution only | No intervention | Control drink containing 50 g carbohydrate |
| Glucose with grass jelly solution | Active comparator | Control drink plus 3.12 g grass jelly powder Receives: Other: Glucose with grass jelly solution |
| Glucose with grass jelly (solid) | Active comparator | Control drink plus 3.12 g grass jelly powder in solid form Receives: Other: Glucose with grass jelly (solid) |
| Porridge and juice only | No intervention | Control breakfast containing 50 g carbohydrate. |
| Porridge and juice with coconut oil | Active comparator | Control breakfast, plus 25g coconut oil Receives: Other: Porridge and juice with coconut oil |
| Porridge and juice with coconut oil gel | Active comparator | Control breakfast, plus 25g coconut oil gel Receives: Other: Porridge and juice with coconut oil gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial blood glucose over 180 minutes period
Blood obtained through fingerprick, analysed using Hemocue analyser. Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Measured: 180 minutes
Change in postprandial plasma triglyceride over 360 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes.
Measured: 360 minutes
Secondary outcomes (1)
Change in postprandial plasma insulin over 360 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma insulin will be assessed at 0, 10, 20, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes.
Measured: 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start12 Jan 2016
- Primary completion27 Jun 2016
- Study completion27 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
- Investigators
- JeyaKumar Christiani, Phd, Principal investigator, Clinical Nutrition Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875275
- Sponsor's protocol ID
- 2015/01098
- Other IDs
- 2015
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid or Solid State of Food on Glycaemia, Lipaemia and Insulinaemia
- ClinicalTrials.gov ID
- NCT02875275
- Acronym / sponsor ID
- 2015/01098
- Conditions
- Diabetes, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- 27 Jun 2016 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.
Detailed description
This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.
Treatments will be randomized to receive 3 different test meals (Oleogel) and/or 3 different test meals. Randomization means assigning the participants to the test meals by chance, like tossing a coin or rolling a dice.
If the participants take part in this study, the participants will be required to come on 3 non-consecutive days and/or 5 non-consecutive days to evaluate the 3 different test meals (Oleogel) and/or 3 different test meal (Grass jelly) respectively, in random order with a minimum of 1 week between the test sessions. For each session, the participants are required to come between 8:00-9:00am, with each session lasting approximately 3.5 hours to 6.5 hours. The participants would have to come following a 10-12 hour overnight fast. An indwelling catheter will be inserted into a vein in the participants' forearm for the remainder of the test session. The investigators will then take a blood sample from the cannula to measure baseline values. The investigators will also take the participant's capillary blood via finger prick to measure blood glucose concentration. After obtaining the baseline blood samples, the investigator will give the participants the test meal to eat within 10 minutes and fill up a 'liking' questionnaire. Following the meal the investigators will take further blood samples (from the cannula and finger pricks) for the next 10, 20, 30, 45, 60, 90, 120, 150, 180, (treatment 4, 5, 6), 210, 240, 270, 300, 330, 360 minutes (Treatment 1, 2, 3).
The amount of blood that will be collected at every time point will be about 5µL droplet from fingerprick and approximately 5mL of blood from cannulation, the accumulative amount per test session will approximately 50 to 80 ml, and the accumulative amount for the entire study duration will be approximately 240 mL of blood by cannula and finger pricks (Part A) and 150 ml (Part B). The investigators will also ask the participants to answer a questionnaire about measurement of hunger and fullness at the same times the blood samples are taken. The appetite-rating questionnaire consists of 100mm continuous lines anchored at each end with opposing statements for a question asked. 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 food do you think you can eat?' and 'Do you have any preoccupation with thoughts of food right now?'. Using a pen, you would have to make a mark on the line corresponding to how you feel.
In addition to the VAS scales, the current trial will collect information on the prospective portion that participants would like to consume for a range of different foods at different time points; at every 30 minutes interval from baseline till the end of each test session. This computer based task presents a range of foods to participants and asks "how much of this food would you like to consume right now?", allowing the participants to move between a series of different portions of each food and select the one that the participants would like to consume at that time based on the participants' feeling of hunger, fullness and desire to eat. The foods will be deliberately chosen to represent common Singaporean meals, desserts and snack foods that are regularly eaten to relieve hunger in different situations and the range of portions available is the same across all foods (20-1200 kcals in 20 kcal steps).
On the evenings before the test sessions, the participants will be expected to come and collect a standard dinner meal. The participants will be advised not to take part in any strenuous physical activities for at least 3 days and avoid caffeine and alcohol consumption the day before the test sessions.
Subjects participation in the study will last a maximum of 20.5 hours (Part A) and 11.5 hours (Part B), include one screening visit lasting around 1 hour.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Glucose Solution only | No intervention | –Control drink containing 50 g carbohydrate |
| Glucose with grass jelly solution | Active comparator | Other: Glucose with grass jelly solutionControl drink plus 3.12 g grass jelly powder |
| Glucose with grass jelly (solid) | Active comparator | Other: Glucose with grass jelly (solid)Control drink plus 3.12 g grass jelly powder in solid form |
| Porridge and juice only | No intervention | –Control breakfast containing 50 g carbohydrate. |
| Porridge and juice with coconut oil | Active comparator | Other: Porridge and juice with coconut oilControl breakfast, plus 25g coconut oil |
| Porridge and juice with coconut oil gel | Active comparator | Other: Porridge and juice with coconut oil gelControl breakfast, plus 25g coconut oil gel |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21-40 years
- Body Mass Index 18-25 kg/m2
- Body weight more than or equals to 45kg
- Normal blood pressure (≤140/90) and normal fasting blood glucose (<6.0 mM)
Key exclusion criteria (6 listed)
- Have major chronic disease such as heart disease, cancer or diabetes mellitus, intolerances or allergies to test products
- User of insulin or drugs known to affect glucose metabolism and body fat distribution
- People with a major medical or surgical event requiring hospitalization within the preceding 3 months
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
- Current smokers
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 |
|---|---|---|
| Glucose with grass jelly solution50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g) | Other | Glucose with grass jelly solution |
| Glucose with grass jelly (solid)50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g) | Other | Glucose with grass jelly (solid) |
| Porridge and juice with coconut oilAdd instant porridge with hot water with oil. Consume with commercially available orange juice | Other | Porridge and juice with coconut oil |
| Porridge and juice with coconut oil gelAdd instant porridge with hot water with oleogel. Consume with commercially available orange juice | Other | Porridge and juice with coconut oil gel |
Primary outcome
Change in postprandial blood glucose over 180 minutes period
Time frame: 180 minutes
Blood obtained through fingerprick, analysed using Hemocue analyser. Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Change in postprandial plasma triglyceride over 360 minutes period
Time frame: 360 minutes
Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes.
1 secondary outcome
Change in postprandial plasma insulin over 360 minutes period
Time frame: 360 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 2 Aug 2017.
- Individual participant dataSharing planned: No
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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.
JeyaKumar Christiani, Phd principal investigator
Clinical Nutrition Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose with grass jelly solution, Glucose with grass jelly (solid) and Porridge and juice with coconut oil in people with Diabetes and Cardiovascular Disease, 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 4 inclusion and 6 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 2 Aug 2017. 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 180 minutes period (time frame: 180 minutes). The study lists 2 primary outcomes in all. 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 2 Aug 2017.