- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868683
The Glycemic Effect of Added Sugar on Bake Beans (GIF)
July 16, 2020 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
12
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 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Glucose Reference 1
Glucose solution containing 30 g of glucose
|
30 g of glucose dissolved in 250 ml of water
|
|
OTHER: Glucose Reference 2
Glucose solution 2 containing 30 g of glucose
|
30 g of glucose dissolved in 250 ml of water
|
|
OTHER: Glucose Reference 3
Glucose solution 3 containing 30 g of glucose
|
30 g of glucose dissolved in 250 ml of water
|
|
EXPERIMENTAL: Sucrose
Sucrose solution containing 30 g of sucrose
|
30 g of Sucrose dissolved in 250 ml of water
|
|
EXPERIMENTAL: Regular Bake beans in tomato sauce
Bake bean in tomato sauce with high levels of sucrose (37%)
|
Bake beans in tomato sauce containing 14 g of sugar
|
|
EXPERIMENTAL: Bake beans in tomato sauce, reduced sugar
Bake bean in tomato sauce with medium levels of sucrose (29.9%)
|
Bake beans in tomato sauce containing 12.2 g of sugar
|
|
EXPERIMENTAL: Bake beans in tomato sauce, low GI
Bake bean in tomato sauce with low levels of sucrose (18.5%)
|
Bake beans in tomato sauce containing 7.2 g of sugar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glucose [
Time Frame: Up to 180 minutes
|
Whole capillary blood glucose will be measure using Hemocue analyser
|
Up to 180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin
Time Frame: Up to 180 minutes
|
Capillary plasma will be measure using Cobas analyser
|
Up to 180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 20, 2018
Primary Completion (ACTUAL)
April 17, 2019
Study Completion (ACTUAL)
April 17, 2019
Study Registration Dates
First Submitted
March 7, 2019
First Submitted That Met QC Criteria
March 7, 2019
First Posted (ACTUAL)
March 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 17, 2020
Last Update Submitted That Met QC Criteria
July 16, 2020
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/00926
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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