NCT03646812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

August 23, 2018

Last Update Submit

August 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Glucose

    Blood will be collected and measured using hemocue analyzer.

    up to 180 minutes

  • Insulin

    Blood will be collected and measured using COBAS analyzer.

    up to 180 minutes

Study Arms (9)

Glucose Reference 1

OTHER

50g of glucose dissolved in 250ml of water to be consumed.

Other: Glucose Reference 1

Glucose Reference 2

OTHER

50g of glucose dissolved in 250ml of water to be consumed.

Other: Glucose Reference 2

Glucose Reference 3

OTHER

50g of glucose dissolved in 250ml of water to be consumed.

Other: Glucose Reference 3

Semolina Penne

EXPERIMENTAL

70g of semolina penne boiled in 1 Litre of water for 11 minutes. Drained and consume immediately.

Other: Semolina Penne

Wholegrain Penne

EXPERIMENTAL

76g of wholegrain penne boiled in 1 Litre of water for 9 minutes. Drained and consume immediately.

Other: Wholegrain Penne

Semolina Spaghetti

EXPERIMENTAL

71g of semolina spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately.

Other: Semolina Spaghetti

Wholegrain Spaghetti

EXPERIMENTAL

76g of wholegrain spaghetti boiled in 1 Litre of water for 8 minutes. Drained and consume immediately.

Other: Wholegrain Spaghetti

Jasmine rice

EXPERIMENTAL

63g of rice cook with 150g of water. Served and consume immediately.

Other: Jasmine Rice

Asian Noodles

EXPERIMENTAL

92.4g of Asian Noodles cook in boiling water for 45 seconds. Drained and consume immediately

Other: Asian Noodles

Interventions

Glucose contains 50g of available carbohydrates

Glucose Reference 1

Glucose contains 50g of available carbohydrates

Glucose Reference 2

Glucose contains 50g of available carbohydrates

Glucose Reference 3

Semolina Penne contains 50g of available carbohydrates

Semolina Penne

Wholegrain Penne contains 50g of available carbohydrates

Wholegrain Penne

Semolina Spaghetti contains 50g of available carbohydrates

Semolina Spaghetti

Wholegrain Spaghetti contains 50g of available carbohydrates

Wholegrain Spaghetti

Jasmine Rice contains 50g of available carbohydrates

Jasmine rice

Asian Noodles contains 50g of available carbohydrates

Asian Noodles

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

August 10, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations