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Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods

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ClinicalTrials.gov Identifier: NCT03646812
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Barilla Singapore Pte Ltd
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Diabetes Other: Glucose Reference 1 Other: Glucose Reference 2 Other: Glucose Reference 3 Other: Semolina Penne Other: Wholegrain Penne Other: Semolina Spaghetti Other: Wholegrain Spaghetti Other: Jasmine Rice Other: Asian Noodles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Glucose Reference 1
50g of glucose dissolved in 250ml of water to be consumed.
Other: Glucose Reference 1
Glucose contains 50g of available carbohydrates

Glucose Reference 2
50g of glucose dissolved in 250ml of water to be consumed.
Other: Glucose Reference 2
Glucose contains 50g of available carbohydrates

Glucose Reference 3
50g of glucose dissolved in 250ml of water to be consumed.
Other: Glucose Reference 3
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.
Other: Semolina Penne
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.
Other: Wholegrain Penne
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.
Other: Semolina Spaghetti
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.
Other: Wholegrain Spaghetti
Wholegrain Spaghetti contains 50g of available carbohydrates

Experimental: Jasmine rice
63g of rice cook with 150g of water. Served and consume immediately.
Other: Jasmine Rice
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
Other: Asian Noodles
Asian Noodles contains 50g of available carbohydrates




Primary Outcome Measures :
  1. Glucose [ Time Frame: up to 180 minutes ]
    Blood will be collected and measured using hemocue analyzer.

  2. Insulin [ Time Frame: up to 180 minutes ]
    Blood will be collected and measured using COBAS analyzer.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646812


Contacts
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Contact: Jeyakumar Christaini Henry, Phd 6407 0793 jeya_henry@sics.a-star.edu.sg
Contact: Chia Winnie, BSc 6407 4049 chia_pei_fen@sics.a-star.edu.sg

Locations
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Singapore
Clinical Nutrition Research Centre Recruiting
Singapore, Singapore, 117599
Contact: JeyaKumar Christiani Henry, Phd    6407 0793    jeya_henry@sics.a-star.edu.sg   
Contact: Winnie Chia, BSc    6407 4049    chia_pei_fen@sics.a-star.edu.sg   
Sponsors and Collaborators
JeyaKumar Henry
Barilla Singapore Pte Ltd

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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03646812     History of Changes
Other Study ID Numbers: 2018/00622
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No