Clinical trial NCT03646812: Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods
Official title: Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Singapore Institute of Food and Biotechnology Innovation
Sponsor class: OTHER_GOV
Collaborators: name: Barilla Singapore Pte Ltd
First posted: 2018-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study is to determine the glycaemic and insulinaemic index of pasta products and local foods. It is hypothesized that different pasta cuts and wholegrain composition of pasta and local foods have different GI depending on the nature of the carbohydrate content and the food structure within each food.

Detailed description: There will be a total of 9 test sessions and each session will last up to 3.5 hours. The order of sessions will be determined with an online randomizer. At each test session, the following procedures will be performed: two finger-prick blood samples, five minutes apart to measure baseline blood glucose and insulin concentrations Subject will be served the test food and to consume within15 minutes Following the test meal, blood samples will be collected at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.

Eligibility criteria: Inclusion Criteria:

* Healthy Asian - Indian and Chinese ethnicity
* Age between 21-40 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure (\<140/90 mmHg)
* Fasting blood glucose \< 6 mmol/L

Exclusion Criteria:

* Is a current smoker
* Is currently pregnant
* Have any metabolic diseases (such as diabetes, hypertension etc)
* Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycemia(glucocorticoids, thyroid hormones, thiazide diuretics)
* Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
* Have any severe food allergy (e.g. anaphylaxis to peanuts)
* Have any known allergies to any food components of the study protocol
* Have active Tuberculosis (TB) or currently receiving treatment for TB
* Have any known Chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
* Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study.
* Have partake in sports at the competitive and/or endurance levels
* Have intentionally restrict food intake

Primary outcomes:
measure: Glucose
timeFrame: up to 180 minutes
measure: Insulin
timeFrame: up to 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Clinical Nutrition Research Centre
Study officials:
References: