Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants

Healthy Clinical Trial

Official title:

Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585427
• Other study ID #: 2014/00719
• Status: Completed
• Phase: N/A
• First received: October 14, 2015
• Last updated: August 1, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Clinical Nutrition Research Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil

Locations

Country	Name	City	State
Singapore	Clinical Nutrition Research Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose response of different treatments	The blood glucose will be measured by finger prick and venous blood collection at the same time points	4 hours postprandial	No
Primary	Insulin response of different treatments	Insulin concentration will be measured by COBAS Roche analyzer e311	4 hours postprandial	No
Primary	Triglycerides response of different treatments	Triglycerides will be measured by COBAS Roche analyzer e411	4 hours postprandial	No
Secondary	Active Glucagon-like peptide 1 response of different treatments	Active Glucagon-like peptide 1 will be measured by Multiplex kits	4 hours postprandial	No
Secondary	Gastric inhibitory polypeptide response of different treatments	Gastric inhibitory polypeptide will be measured by Multiplex kits	4 hours postprandial	No