Glucose ResponsePARBONCT02969057
Palm And Rice Bran Oil Study
A study testing Breakfast with rice bran oil gel, Breakfast with rice bran oil and Breakfast with palm oil gel in people with Glucose Response, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
The objective of the present study is to compare the effects of liquid or solid state of food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be recruited from the general public in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Response
- What is being tested?
- Breakfast with rice bran oil gel, Breakfast with rice bran oil and Breakfast with palm oil gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2016to Oct 2017
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese male
- Age between 21 and 45 years
- BMI 18-25 kg/m2
- Body weight >/=45 kg
- Normal Blood Pressure (=140/90 mmHg)
- Normal Fasting Blood Glucose (<6.0 mM)
Who cannot join
- People who take part in sports at competitive/endurance levels•
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- People who are glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- People who have intolerances or allergies to test products
- Individuals who are taking 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 three months
Show all 9Show fewer
- Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
- People who are on any therapeutic diet/ drug therapy
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Liquid Oil vs Oleogel Co-ingested With a Carbohydrate-rich Meal on Human Blood Triglycerides, Glucose, Insulin and Appetite.
The objective of the present study is to compare the effects of liquid or solid state of food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be recruited from the general public in Singapore. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of one test per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. We have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required. All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal. Participants will be provided with some snacks at the end of each testing session. They will also be reimbursed to compensate for their time and costs associated with travel and parking at the completion of the study. In addition, participants will be provided with their blood glucose, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.
Read the detailed description
Design: This will be a randomised, crossover study with five sessions in total. 1.) Instant rice porridge with orange juice, 2.) Instant rice porridge with palm oil, with orange juice 3.) Instant rice porridge with palm oleogel, with orange juice 4.) Instant rice porridge with liquid rice bran oil, with orange juice 5.) Instant rice porridge with rice bran oleogel, with orange juice
Study population: Healthy Chinese males (BMI 18-25 kgm-2) with body weight >/=45 kg, aged 21-45 years with normal fasting blood glucose (<6.0 mM), will be recruited from the general public in Singapore. The exclusion criteria are people with major chronic disease such as heart disease, cancer or diabetes mellitus, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, glucose intolerance, intolerances or allergies to test products, as well as individuals who are taking insulin or drugs known to affect glucose metabolism. 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, people who are on any therapeutic diet/ drug therapy and smokers will be excluded.
Screening visit: 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. 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 physical activity level will be collected from each participant in order to determine their eligibility. 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. Participants will then be scheduled for the 5 subsequent test visits. The screening visit will take approximately 1 hour.
Screening questionnaire: The screening questionnaire will include contact information, 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. Physical activity level will be measured using a previously validated international physical activity questionnaire.
Meal composition: The test meal will consist of cooking oil (palm oil or rice bran oil in either liquid or gelled form made with ethylcellulose), orange juice and commercially available instant porridge.
Test visits: During the testing sessions, participants' glycaemic, insulinaemic, and lipaemic responses to the test meals will be measured. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. The test duration for each treatment is 6.5 hours and the testing sessions will take place at least 1 week apart. Subjects 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 asked to standardise their diets and to refrain from alcohol and exercise the day before their testing sessions. At the beginning of the testing session, a cannula will be inserted into participants' arms. One fasting blood sample will be collected by fingerprick and venous cannulation. A drop of blood will be collected into a HemoCue® cuvette (Helsingborg, Sweden) for blood glucose analysis. In addition, 5 milliliters of venous blood will be collected into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA for the analyses of plasma triglyceride, insulin and non-esterified fatty acids concentrations. Participants will then consume treatment meal within 10 minutes. Blood samples will be taken at baseline, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes. The amount of blood that will be collected at every time point will be approximately 5 mL. A maximum of 16 blood samples for will be collected by fingerprick and cannulation. A total of 400mL approximately of blood will be taken for the study. Glycaemic, insulinaemic, and lipaemic 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.
Participants will also be asked to rate their 'liking' for the test meal. Participants will rate their 'overall liking' for the test meal on a 100 mm VAS anchored with 'dislike extremely' (0 mm), 'neither like or dislike' (50 mm) and 'like extremely' (100 mm) immediately after they consume the test meal. Metabolic satiety: On the testing session days, participants will be asked to record their appetite ratings on a 100 mm visual analogue scale (VAS) immediately before they consume the test meal, then at every 30 minutes interval as peak changes are usually observed at 15-30 minutes after a test meal, based on previous studies.. The appetite-rating questionnaire will include questions on hunger, desire to eat, prospective consumption, fullness, and preoccupation with thoughts of food.
- Conditions
- Glucose Response
- Being tested
- Breakfast with rice bran oil gel, Breakfast with rice bran oil, Breakfast with palm oil gel, Breakfast with palm oil
- Keywords
- Lipidemic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast with rice bran oil gelOther
25 grams of rice bran oil gel
Breakfast with rice bran oilOther
25 grams of rice bran oil
Breakfast with palm oil gelOther
25 grams of palm oil gel
Breakfast with palm oilOther
25 grams of palm oil
| Study group | Role | What they receive |
|---|---|---|
| Breakfast only | No intervention | Control breakfast providing 50g carbohydrate |
| Breakfast with rice bran oil gel | Active comparator | Control breakfast, plus 25g rice bran oil gel (solid) Receives: Other: Breakfast with rice bran oil gel |
| Breakfast with rice bran oil | Active comparator | Control breakfast, plus 25g rice bran oil (liquid) Receives: Other: Breakfast with rice bran oil |
| Breakfast with palm oil gel | Active comparator | Control breakfast, plus 25g palm oil gel (solid) Receives: Other: Breakfast with palm oil gel |
| Breakfast with palm oil | Active comparator | Control breakfast, plus 25g palm oil (liquid) Receives: Other: Breakfast with palm oil |
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.
Measured: 180 minutes
Change in postprandial serum triglyceride over 360 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
Measured: 360 minutes
Change in postprandial serum glucose over 360 minutes period
Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
Measured: 360 minutes
Secondary outcomes (2)
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, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
Measured: 360 minutes
Change in postprandial appetite over 360 minutes period
Appetite ratings will be assessed at 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 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 posted21 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose ResponseStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Collaborators
- University of Guelph
- Responsible party
- Principal investigator, JeyaKumar Henry, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969057
- Sponsor's protocol ID
- 2016/00932
- Other IDs
- 2016
- Acronym
- PARBO
- Status last verified
- Jul 2018
- First submitted
- 17 Nov 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan SY, Peh E, Siow PC, Marangoni AG, Henry CJ. Effects of the physical-form and the degree-of-saturation of oil on postprandial plasma triglycerides, glycemia and appetite of healthy Chinese adults. Food Funct. 2017 Dec 13;8(12):4433-4440. doi: 10.1039/c7fo01194f.
PubMed 29090299
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liquid Oil vs Oleogel Co-ingested With a Carbohydrate-rich Meal on Human Blood Triglycerides, Glucose, Insulin and Appetite.
- ClinicalTrials.gov ID
- NCT02969057
- Acronym / sponsor ID
- PARBO / 2016/00932
- Conditions
- Glucose Response
- Keywords
- Lipidemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Collaborators
- University of Guelph
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Nov 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.
The objective of the present study is to compare the effects of liquid or solid state of food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be recruited from the general public in Singapore. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of one test per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. We have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required. All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal. Participants will be provided with some snacks at the end of each testing session. They will also be reimbursed to compensate for their time and costs associated with travel and parking at the completion of the study. In addition, participants will be provided with their blood glucose, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.
Detailed description
Design: This will be a randomised, crossover study with five sessions in total. 1.) Instant rice porridge with orange juice, 2.) Instant rice porridge with palm oil, with orange juice 3.) Instant rice porridge with palm oleogel, with orange juice 4.) Instant rice porridge with liquid rice bran oil, with orange juice 5.) Instant rice porridge with rice bran oleogel, with orange juice
Study population: Healthy Chinese males (BMI 18-25 kgm-2) with body weight >/=45 kg, aged 21-45 years with normal fasting blood glucose (<6.0 mM), will be recruited from the general public in Singapore. The exclusion criteria are people with major chronic disease such as heart disease, cancer or diabetes mellitus, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, glucose intolerance, intolerances or allergies to test products, as well as individuals who are taking insulin or drugs known to affect glucose metabolism. 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, people who are on any therapeutic diet/ drug therapy and smokers will be excluded.
Screening visit: 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. 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 physical activity level will be collected from each participant in order to determine their eligibility. 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. Participants will then be scheduled for the 5 subsequent test visits. The screening visit will take approximately 1 hour.
Screening questionnaire: The screening questionnaire will include contact information, 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. Physical activity level will be measured using a previously validated international physical activity questionnaire.
Meal composition: The test meal will consist of cooking oil (palm oil or rice bran oil in either liquid or gelled form made with ethylcellulose), orange juice and commercially available instant porridge.
Test visits: During the testing sessions, participants' glycaemic, insulinaemic, and lipaemic responses to the test meals will be measured. Participants' metabolic satiety for the test meals will also be assessed at regular intervals throughout the testing session. The test duration for each treatment is 6.5 hours and the testing sessions will take place at least 1 week apart. Subjects 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 asked to standardise their diets and to refrain from alcohol and exercise the day before their testing sessions. At the beginning of the testing session, a cannula will be inserted into participants' arms. One fasting blood sample will be collected by fingerprick and venous cannulation. A drop of blood will be collected into a HemoCue® cuvette (Helsingborg, Sweden) for blood glucose analysis. In addition, 5 milliliters of venous blood will be collected into Vacutainers® (Belton Dickinson Diagnostics) containing disodium EDTA for the analyses of plasma triglyceride, insulin and non-esterified fatty acids concentrations. Participants will then consume treatment meal within 10 minutes. Blood samples will be taken at baseline, 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes. The amount of blood that will be collected at every time point will be approximately 5 mL. A maximum of 16 blood samples for will be collected by fingerprick and cannulation. A total of 400mL approximately of blood will be taken for the study. Glycaemic, insulinaemic, and lipaemic 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.
Participants will also be asked to rate their 'liking' for the test meal. Participants will rate their 'overall liking' for the test meal on a 100 mm VAS anchored with 'dislike extremely' (0 mm), 'neither like or dislike' (50 mm) and 'like extremely' (100 mm) immediately after they consume the test meal. Metabolic satiety: On the testing session days, participants will be asked to record their appetite ratings on a 100 mm visual analogue scale (VAS) immediately before they consume the test meal, then at every 30 minutes interval as peak changes are usually observed at 15-30 minutes after a test meal, based on previous studies.. The appetite-rating questionnaire will include questions on hunger, desire to eat, prospective consumption, fullness, and preoccupation with thoughts of food.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Breakfast only | No intervention | –Control breakfast providing 50g carbohydrate |
| Breakfast with rice bran oil gel | Active comparator | Other: Breakfast with rice bran oil gelControl breakfast, plus 25g rice bran oil gel (solid) |
| Breakfast with rice bran oil | Active comparator | Other: Breakfast with rice bran oilControl breakfast, plus 25g rice bran oil (liquid) |
| Breakfast with palm oil gel | Active comparator | Other: Breakfast with palm oil gelControl breakfast, plus 25g palm oil gel (solid) |
| Breakfast with palm oil | Active comparator | Other: Breakfast with palm oilControl breakfast, plus 25g palm oil (liquid) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Chinese male
- Age between 21 and 45 years
- BMI 18-25 kg/m2
- Body weight >/=45 kg
- Normal Blood Pressure (=140/90 mmHg)
Key exclusion criteria (9 listed)
- People who take part in sports at competitive/endurance levels•
- People with major chronic disease such as heart disease, cancer or diabetes mellitus
- People who are glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
- People who have intolerances or allergies to test products
- Individuals who are taking insulin or drugs known to affect glucose metabolism and body fat distribution
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 |
|---|---|---|
| Breakfast with rice bran oil gel25 grams of rice bran oil gel | Other | Breakfast with rice bran oil gel |
| Breakfast with rice bran oil25 grams of rice bran oil | Other | Breakfast with rice bran oil |
| Breakfast with palm oil gel25 grams of palm oil gel | Other | Breakfast with palm oil gel |
| Breakfast with palm oil25 grams of palm oil | Other | Breakfast with palm oil |
Primary outcome
Change in postprandial blood glucose over 180 minutes period
Time frame: 180 minutes
Blood obtained through fingerprick, analysed using Hemocue analyser.
Change in postprandial serum 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, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
Change in postprandial serum glucose 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, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
2 secondary outcomes
Change in postprandial plasma insulin over 360 minutes period
Time frame: 360 minutes
Change in postprandial appetite 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 18 Jul 2018.
- Derived from this study: PubMed 29090299Tan SY, Peh E, Siow PC, Marangoni AG, Henry CJ. Effects of the physical-form and the degree-of-saturation of oil on postprandial plasma triglycerides, glycemia and appetite of healthy Chinese adults. Food Funct. 2017 Dec 13;8(12):4433-4440. doi: 10.1039/c7fo01194f.
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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 Breakfast with rice bran oil gel, Breakfast with rice bran oil and Breakfast with palm oil gel in people with Glucose Response, 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 6 inclusion and 9 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 18 Jul 2018. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969057, which also lists 1 linked publication.
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 18 Jul 2018.