NCT03868683

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

July 17, 2020

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

March 7, 2019

Last Update Submit

July 16, 2020

Conditions

Diabetes Mellitus, Type 2ObesityPreDiabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose [

    Whole capillary blood glucose will be measure using Hemocue analyser

    Up to 180 minutes

Secondary Outcomes (1)

  • Insulin

    Up to 180 minutes

Study Arms (7)

Glucose Reference 1

OTHER

Glucose solution containing 30 g of glucose

Other: Glucose Reference 1

Glucose Reference 2

OTHER

Glucose solution 2 containing 30 g of glucose

Other: Glucose Reference 2

Glucose Reference 3

OTHER

Glucose solution 3 containing 30 g of glucose

Other: Glucose reference 3

Sucrose

EXPERIMENTAL

Sucrose solution containing 30 g of sucrose

Other: Sucrose

Regular Bake beans in tomato sauce

EXPERIMENTAL

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

Other: Regular Bake beans in tomato sauce

Bake beans in tomato sauce, reduced sugar

EXPERIMENTAL

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, low GI

EXPERIMENTAL

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

Other: Bake beans in tomato sauce, low GI

Interventions

Glucose Reference 1OTHER

30 g of glucose dissolved in 250 ml of water

Glucose Reference 1
Glucose Reference 2OTHER

30 g of glucose dissolved in 250 ml of water

Glucose Reference 2
Glucose reference 3OTHER

30 g of glucose dissolved in 250 ml of water

Glucose Reference 3
SucroseOTHER

30 g of Sucrose dissolved in 250 ml of water

Sucrose
Regular Bake beans in tomato sauceOTHER

Bake beans in tomato sauce containing 14 g of sugar

Regular Bake beans in tomato sauce
Bake beans in tomato sauce, reduced sugarOTHER

Bake beans in tomato sauce containing 12.2 g of sugar

Bake beans in tomato sauce, reduced sugar
Bake beans in tomato sauce, low GIOTHER

Bake beans in tomato sauce containing 7.2 g of sugar

Bake beans in tomato sauce, low GI

Eligibility Criteria

Age21 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsHealthy Male Volunteers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityPrediabetic State

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover randomized controlled Trials
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 11, 2019

Study Start

August 20, 2018

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

July 17, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)