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Food Modification to Alter Glycaemia and Insulinaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706378
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Health Promotion Board, Singapore
Information provided by (Responsible Party):
JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore

Study Description
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Brief Summary:
The study specifically aims to determine glycemic and insulinemic response of added low GI ingredients, beta-glucan, resistant starch and isomaltulose to foods.

Condition or disease Intervention/treatment Phase
Diabetes Other: Glucose Reference 1 Other: Glucose Reference 2 Other: Glucose Reference 3 Other: Wheat Yellow Noodle Other: Beta-glucan yellow Noodle Other: Rice Roll Other: Rice Roll with resistant starch Other: Sucrose Jelly Other: Isomaltulose Jelly Not Applicable

Detailed Description:
There will be a total of 9 test sessions and each session will last up to 3 hours. 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Food Modification to Alter Glycaemia and Insulinaemia
Actual Study Start Date : August 18, 2017
Actual Primary Completion Date : April 4, 2019
Actual Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
Glucose Reference 1
50g glucose dissolve in 250 ml of water
 Other: Glucose Reference 1
Glucose contains 50g of available carbohydrates
Glucose Reference 2
50g glucose dissolve in 250 ml of water
 Other: Glucose Reference 2
Glucose contains 50g of available carbohydrates
Glucose Reference 3
50g glucose dissolve in 250 ml of water
 Other: Glucose Reference 3
Glucose contains 50g of available carbohydrates
Experimental: Wheat Yellow Noodle
Boiled 170.6g of wheat yellow noodle
 Other: Wheat Yellow Noodle
Wheat Yellow Noodle will contain 50g of available carbohydrate
Experimental: Beta-glucan Yellow Noodle
Boiled 230.4g of beta-glucan yellow noodle.
 Other: Beta-glucan yellow Noodle
Beta-glucan yellow noodle will contain 50g of available carbohydrate
Experimental: Rice Roll
Steamed 197.6g of rice roll
 Other: Rice Roll
Rice Roll will contain 50g of available carbohydrate
Experimental: Rice Roll with resistant starch
Steamed 232.6g of rice roll fortified with resistant starch
 Other: Rice Roll with resistant starch
Rice Roll fortified with resistant starch will contain 50g of available carbohydrate
Experimental: Sucrose jelly
Jelly made with 25g of sucrose and 48g of wheat white bread
 Other: Sucrose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose
Experimental: Isomaltulose jelly
Jelly made with 25g of isomaltulose and 48g of wheat white bread
 Other: Isomaltulose Jelly
Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose


Outcome Measures
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Primary Outcome Measures :
  1. Glucose [ Time Frame: up to 180 minutes ]
    Blood glucose will be collected using finger prick method and analysed using Hemocue analyser

  2. Insulin [ Time Frame: up to 180 minutes ]
    Blood glucose will be collected using finger prick method and analysed using Cobas analyser


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy male participants
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Males
  • Chinese ethnicity
  • Age ≥21 and ≤ 40 years
  • Body mass index between 18.5 to 25 kg/m2
  • Normal blood pressure ≤140/90 mmHg
  • Fasting blood glucose <6.0 mmol/L
  • In general good health

Exclusion Criteria:

  • Current smoker
  • Have metabolic diseases (such as diabetes, hypertension etc)
  • Have glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
  • Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
  • Have an ongoing infection or currently undergoing treatment at the time of screening
  • Have 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)
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Intolerances or allergies to any foods
  • Partake in sports at the competitive and/or endurance levels
  • Intentionally restrict food intake
Contacts and Locations
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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): NCT03706378


Locations
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Singapore
Clinical Nutrition Research Centre
Singapore, Singapore, 117599
Sponsors and Collaborators
Clinical Nutrition Research Centre, Singapore
Health Promotion Board, Singapore
More Information
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Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
ClinicalTrials.gov Identifier: NCT03706378    
Other Study ID Numbers: 2017/00538
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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