- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02969057
Palm And Rice Bran Oil Study (PARBO)
Effects of Liquid Oil vs Oleogel Co-ingested With a Carbohydrate-rich Meal on Human Blood Triglycerides, Glucose, Insulin and Appetite.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore
- JeyaKumar Henry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Breakfast only
Control breakfast providing 50g carbohydrate
|
|
Active Comparator: Breakfast with rice bran oil gel
Control breakfast, plus 25g rice bran oil gel (solid)
|
25 grams of rice bran oil gel
|
Active Comparator: Breakfast with rice bran oil
Control breakfast, plus 25g rice bran oil (liquid)
|
25 grams of rice bran oil
|
Active Comparator: Breakfast with palm oil gel
Control breakfast, plus 25g palm oil gel (solid)
|
25 grams of palm oil gel
|
Active Comparator: Breakfast with palm oil
Control breakfast, plus 25g palm oil (liquid)
|
25 grams of palm oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postprandial blood glucose over 180 minutes period
Time Frame: 180 minutes
|
Blood obtained through fingerprick, analysed using Hemocue analyser.
|
180 minutes
|
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
|
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
|
360 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in postprandial plasma insulin over 360 minutes period
Time Frame: 360 minutes
|
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
|
360 minutes
|
Change in postprandial appetite over 360 minutes period
Time Frame: 360 minutes
|
Appetite ratings will be assessed at 10, 20, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes
|
360 minutes
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016/00932
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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