- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02585427
Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants
It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight management tool has been increasing. Different types of carbohydrates differ in their ability to increase postprandial blood glucose and insulin secretion, and may also modulate the effect of different fatty acids. The current study will compare the consumption of low and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and triacylglycerol responses in healthy participants.
The data generated will have direct applications in public health policy and clinical nutrition management of chronic disease. The outcomes of the study will significantly contribute to the long term national goals of Singapore to manage and to reduce the incidence of chronic disease associated with the metabolic syndrome.
Study Overview
Status
Conditions
Detailed Description
This study will be conducted using a randomized, crossover design with six dietary phases: a low GI meal or a high GI meal with saturated fat, monounsaturated fat or polyunsaturated fat. All participants will be randomly allocated to the six test meals, with the order balanced. Fifteen participants aged between 21 and 40 years will be recruited from the general public in Singapore. During the testing session, a maximum of eleven blood samples will be collected by fingerpricks and cannulation. 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 two tests 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. The investigators 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.
A number of dietary interventions have aimed to investigate the effect of dietary fat quality on glucose, insulin and lipidemia response. Up to now there have been few studies connect the glycaemic load and fat quality together. The investigators study's results will help public choose fat quality and carbohydrate quality in the diet. Participants will be provided with some snacks at the end of each testing session.
In addition, participants will be provided with their blood glucose, blood insulin, blood lipid profile, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy Chinese male subjects aged between 21 and 40 years
- Do not have major chronic disease such as heart disease, cancer or diabetes mellitus
- Do not have family history of diabetes
- Do not have intolerances or allergies to test products(wheat and milk based products)
- Not taking insulin or drugs known to affect glucose or triglyceride levels and body fat distribution
- Do not have major medical or surgical event requiring hospitalization within the preceding three months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low glycemic index rice with butter
50 g available low glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid)
|
|
|
Experimental: low glycemic index rice with olive oil
50 g available low glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid)
|
|
|
Experimental: low glycemic index rice with grapeseed oil
50 g available low glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid)
|
|
|
Experimental: high glycemic index rice with butter
50 g available high glycemic index rice cooked with 48 g butter ( equal 40 g saturated fatty acid)
|
|
|
Experimental: high glycemic index rice with olive oil
50 g available high glycemic index rice cooked with 44 g olive oil ( equal 40 g monounsaturated fatty acid)
|
|
|
Experimental: high glycemic index rice with grapeseed oil
50 g available high glycemic index rice cooked with 40 g grapeseed oil ( equal 40 g polyunsaturated fatty acid)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose response of different treatments
Time Frame: 4 hours postprandial
|
The blood glucose will be measured by finger prick and venous blood collection at the same time points
|
4 hours postprandial
|
|
Insulin response of different treatments
Time Frame: 4 hours postprandial
|
Insulin concentration will be measured by COBAS Roche analyzer e311
|
4 hours postprandial
|
|
Triglycerides response of different treatments
Time Frame: 4 hours postprandial
|
Triglycerides will be measured by COBAS Roche analyzer e411
|
4 hours postprandial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Glucagon-like peptide 1 response of different treatments
Time Frame: 4 hours postprandial
|
Active Glucagon-like peptide 1 will be measured by Multiplex kits
|
4 hours postprandial
|
|
Gastric inhibitory polypeptide response of different treatments
Time Frame: 4 hours postprandial
|
Gastric inhibitory polypeptide will be measured by Multiplex kits
|
4 hours postprandial
|
Collaborators and Investigators
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2014/00719
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil
-
Federico II UniversityUnknown
-
University of TorontoCanola Council of CanadaCompleted
-
Shenzhen Institutes of Advanced Technology ,Chinese...CompletedHealthy | Food Preferences | HungerChina
-
Universidad de ValparaisoCompletedDiabetes Mellitus, Type 2
-
Clinical Nutrition Research Centre, SingaporeHealth Promotion Board, SingaporeCompleted
-
Caio Eduardo Gonçalves ReisUniversity of Brasilia; Conselho Nacional de Desenvolvimento Científico e Tecnológico and other collaboratorsCompleted
-
University of CopenhagenLund University Hospital; Danone Vitapole, France.; Masterfoods Denmark; Euryza... and other collaboratorsCompletedObesity | Overweight
-
Clinical Nutrition Research Centre, SingaporeUniversity of Auckland, New Zealand; Massey University; Riddet UniversityCompleted
-
University of NottinghamRecruitingFatty Liver | Nutritional and Metabolic DiseaseUnited Kingdom
-
USDA, Western Human Nutrition Research CenterCompletedDietary Modification | Exogenous ObesityUnited States