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The Glycemic Effect of Added Sugar on Bake Beans (GIF)

Primary Purpose

Diabetes Mellitus, Type 2, Obesity, PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Glucose Reference 1
Glucose Reference 2
Glucose reference 3
Sucrose
Regular Bake beans in tomato sauce
Bake beans in tomato sauce, reduced sugar
Bake beans in tomato sauce, low GI
Sponsored by
Clinical Nutrition Research Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Chinese ethnicity
  • Age ≥21 and ≤ 60 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 any metabolic diseases (such as diabetes, hypertension etc)
  • have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
  • having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
  • have intolerances or allergies to any foods
  • partake in sports at the competitive and/or endurance levels
  • intentionally restrict food intake

Sites / Locations

  • Clinical Nutrition Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Other

Other

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose Reference 1

Glucose Reference 2

Glucose Reference 3

Sucrose

Regular Bake beans in tomato sauce

Bake beans in tomato sauce, reduced sugar

Bake beans in tomato sauce, low GI

Arm Description

Glucose solution containing 30 g of glucose

Glucose solution 2 containing 30 g of glucose

Glucose solution 3 containing 30 g of glucose

Sucrose solution containing 30 g of sucrose

Bake bean in tomato sauce with high levels of sucrose (37%)

Bake bean in tomato sauce with medium levels of sucrose (29.9%)

Bake bean in tomato sauce with low levels of sucrose (18.5%)

Outcomes

Primary Outcome Measures

Glucose [
Whole capillary blood glucose will be measure using Hemocue analyser

Secondary Outcome Measures

Insulin
Capillary plasma will be measure using Cobas analyser

Full Information

First Posted
March 7, 2019
Last Updated
July 16, 2020
Sponsor
Clinical Nutrition Research Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03868683
Brief Title
The Glycemic Effect of Added Sugar on Bake Beans
Acronym
GIF
Official Title
The Glycemic Effect of Added Sugar on Bake Beans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Nutrition Research Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.
Detailed Description
There will be a total of 7 test session. Each session will last for 3 hours. At each test session, volunteers will be served with 7 test meals and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerpick. Following the fasting samples, volunteers will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity, PreDiabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover randomized controlled Trials
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose Reference 1
Arm Type
Other
Arm Description
Glucose solution containing 30 g of glucose
Arm Title
Glucose Reference 2
Arm Type
Other
Arm Description
Glucose solution 2 containing 30 g of glucose
Arm Title
Glucose Reference 3
Arm Type
Other
Arm Description
Glucose solution 3 containing 30 g of glucose
Arm Title
Sucrose
Arm Type
Experimental
Arm Description
Sucrose solution containing 30 g of sucrose
Arm Title
Regular Bake beans in tomato sauce
Arm Type
Experimental
Arm Description
Bake bean in tomato sauce with high levels of sucrose (37%)
Arm Title
Bake beans in tomato sauce, reduced sugar
Arm Type
Experimental
Arm Description
Bake bean in tomato sauce with medium levels of sucrose (29.9%)
Arm Title
Bake beans in tomato sauce, low GI
Arm Type
Experimental
Arm Description
Bake bean in tomato sauce with low levels of sucrose (18.5%)
Intervention Type
Other
Intervention Name(s)
Glucose Reference 1
Intervention Description
30 g of glucose dissolved in 250 ml of water
Intervention Type
Other
Intervention Name(s)
Glucose Reference 2
Intervention Description
30 g of glucose dissolved in 250 ml of water
Intervention Type
Other
Intervention Name(s)
Glucose reference 3
Intervention Description
30 g of glucose dissolved in 250 ml of water
Intervention Type
Other
Intervention Name(s)
Sucrose
Intervention Description
30 g of Sucrose dissolved in 250 ml of water
Intervention Type
Other
Intervention Name(s)
Regular Bake beans in tomato sauce
Intervention Description
Bake beans in tomato sauce containing 14 g of sugar
Intervention Type
Other
Intervention Name(s)
Bake beans in tomato sauce, reduced sugar
Intervention Description
Bake beans in tomato sauce containing 12.2 g of sugar
Intervention Type
Other
Intervention Name(s)
Bake beans in tomato sauce, low GI
Intervention Description
Bake beans in tomato sauce containing 7.2 g of sugar
Primary Outcome Measure Information:
Title
Glucose [
Description
Whole capillary blood glucose will be measure using Hemocue analyser
Time Frame
Up to 180 minutes
Secondary Outcome Measure Information:
Title
Insulin
Description
Capillary plasma will be measure using Cobas analyser
Time Frame
Up to 180 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy Male Volunteers
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chinese ethnicity Age ≥21 and ≤ 60 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 any metabolic diseases (such as diabetes, hypertension etc) have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) having medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics) have intolerances or allergies to any foods partake in sports at the competitive and/or endurance levels intentionally restrict food intake
Facility Information:
Facility Name
Clinical Nutrition Research Centre
City
Singapore
ZIP/Postal Code
117599
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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The Glycemic Effect of Added Sugar on Bake Beans

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