GIF: The Glycemic Effect of Added Sugar on Bake Beans

• Sponsor: Clinical Nutrition Research Centre, Singapore (Other)
• Overall Status: Completed
• CT.gov ID: NCT03868683
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 7
• Actual Duration (Months): 7.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

To investigate the effect of added sugar to bake beans on glycemic and insulinemic response.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Obesity; PreDiabetes	Other: Glucose Reference 1; Other: Glucose Reference 2; Other: Glucose reference 3; Other: Sucrose; Other: Regular Bake beans in tomato sauce; Other: Bake beans in tomato sauce, reduced sugar; Other: Bake beans in tomato sauce, low GI	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Crossover randomized controlled TrialsCrossover randomized controlled Trials
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Glycemic Effect of Added Sugar on Bake Beans
• Actual Study Start Date: Aug 20, 2018
• Actual Primary Completion Date: Apr 17, 2019
• Actual Study Completion Date: Apr 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Glucose Reference 1 Glucose solution containing 30 g of glucose	Other: Glucose Reference 1; 30 g of glucose dissolved in 250 ml of water
Other: Glucose Reference 2 Glucose solution 2 containing 30 g of glucose	Other: Glucose Reference 2; 30 g of glucose dissolved in 250 ml of water
Other: Glucose Reference 3 Glucose solution 3 containing 30 g of glucose	Other: Glucose reference 3; 30 g of glucose dissolved in 250 ml of water
Experimental: Sucrose Sucrose solution containing 30 g of sucrose	Other: 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%)	Other: Regular Bake beans in tomato sauce; 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%)	Other: Bake beans in tomato sauce, reduced sugar; 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%)	Other: Bake beans in tomato sauce, low GI; Bake beans in tomato sauce containing 7.2 g of sugar

Outcome Measures

Primary Outcome Measures

1. Glucose [ [Up to 180 minutes]

   Whole capillary blood glucose will be measure using Hemocue analyser

Secondary Outcome Measures

1. Insulin [Up to 180 minutes]

   Capillary plasma will be measure using Cobas analyser

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Centre	Singapore		Singapore	117599

Sponsors and Collaborators

• Clinical Nutrition Research Centre, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JeyaKumar Henry, Principal Investigator, Clinical Nutrition Research Centre, Singapore
• ClinicalTrials.gov Identifier: NCT03868683
• Other Study ID Numbers: 2016/00926
• First Posted: Mar 11, 2019
• Last Update Posted: Jul 17, 2020
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 17, 2020