- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646812
Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods
August 29, 2023 updated by: Clinical Nutrition Research Centre, Singapore
Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 117599
- Clinical Nutrition Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Glucose Reference 1
50g of glucose dissolved in 250ml of water to be consumed.
|
Glucose contains 50g of available carbohydrates
|
Other: Glucose Reference 2
50g of glucose dissolved in 250ml of water to be consumed.
|
Glucose contains 50g of available carbohydrates
|
Other: Glucose Reference 3
50g of glucose dissolved in 250ml of water to be consumed.
|
Glucose contains 50g of available carbohydrates
|
Experimental: Semolina Penne
70g of semolina penne boiled in 1 Litre of water for 11 minutes.
Drained and consume immediately.
|
Semolina Penne contains 50g of available carbohydrates
|
Experimental: Wholegrain Penne
76g of wholegrain penne boiled in 1 Litre of water for 9 minutes.
Drained and consume immediately.
|
Wholegrain Penne contains 50g of available carbohydrates
|
Experimental: Semolina Spaghetti
71g of semolina spaghetti boiled in 1 Litre of water for 8 minutes.
Drained and consume immediately.
|
Semolina Spaghetti contains 50g of available carbohydrates
|
Experimental: Wholegrain Spaghetti
76g of wholegrain spaghetti boiled in 1 Litre of water for 8 minutes.
Drained and consume immediately.
|
Wholegrain Spaghetti contains 50g of available carbohydrates
|
Experimental: Jasmine rice
63g of rice cook with 150g of water.
Served and consume immediately.
|
Jasmine Rice contains 50g of available carbohydrates
|
Experimental: Asian Noodles
92.4g of Asian Noodles cook in boiling water for 45 seconds.
Drained and consume immediately
|
Asian Noodles contains 50g of available carbohydrates
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose
Time Frame: up to 180 minutes
|
Blood will be collected and measured using hemocue analyzer.
|
up to 180 minutes
|
Insulin
Time Frame: up to 180 minutes
|
Blood will be collected and measured using COBAS analyzer.
|
up to 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2018
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
August 23, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 29, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2018/00622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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