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Palm And Rice Bran Oil Study (PARBO)

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ClinicalTrials.gov Identifier: NCT02969057
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
University of Guelph
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Glucose Response Other: Breakfast with rice bran oil gel Other: Breakfast with rice bran oil Other: Breakfast with palm oil gel Other: Breakfast with palm oil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Liquid Oil vs Oleogel Co-ingested With a Carbohydrate-rich Meal on Human Blood Triglycerides, Glucose, Insulin and Appetite.
Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Palm oil

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)
Other: Breakfast with rice bran oil gel
25 grams of rice bran oil gel

Active Comparator: Breakfast with rice bran oil
Control breakfast, plus 25g rice bran oil (liquid)
Other: Breakfast with rice bran oil
25 grams of rice bran oil

Active Comparator: Breakfast with palm oil gel
Control breakfast, plus 25g palm oil gel (solid)
Other: Breakfast with palm oil gel
25 grams of palm oil gel

Active Comparator: Breakfast with palm oil
Control breakfast, plus 25g palm oil (liquid)
Other: Breakfast with palm oil
25 grams of palm oil




Primary Outcome Measures :
  1. Change in postprandial blood glucose over 180 minutes period [ Time Frame: 180 minutes ]
    Blood obtained through fingerprick, analysed using Hemocue analyser.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969057


Locations
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Singapore
JeyaKumar Henry
Singapore, Singapore
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
University of Guelph

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: JeyaKumar Henry, Principle Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT02969057     History of Changes
Other Study ID Numbers: 2016/00932
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore:
Lipidemic Response