NCT03279107

Brief Summary

The aim of the study is to describe the glycemic, insulinemic and appetitive responses to liquid and solid foods where either soluble fiber or maltodextrin are used as the carbohydrate substrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

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 25, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

September 6, 2017

Last Update Submit

August 19, 2021

Conditions

Pre DiabetesObesity

Outcome Measures

Primary Outcomes (2)

  • Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).

    Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

    up to 180 minutes

  • Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).

    Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.

    up to 180 minutes

Secondary Outcomes (1)

  • Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).

    up to 180 minutes

Study Arms (5)

Control beverage with glucose powder

NO INTERVENTION

Standard glucose beverage with 50 g of glucose powder

Beverage with soluble corn fiber

EXPERIMENTAL

Beverage with soluble corn fiber (50 gram of total carbohydrate)

Other: Soluble corn fiber

Beverage with maltodextrin

EXPERIMENTAL

Beverage with maltodextrin (50 gram of total carbohydrate)

Other: maltodextrin

Snack with soluble corn fiber

EXPERIMENTAL

snack with soluble corn fiber (50 gram of total carbohydrate)

Other: Soluble corn fiber

Snack with maltodextrin

EXPERIMENTAL

Snack with maltodextrin (50 gram of total carbohydrate)

Other: maltodextrin

Interventions

Soluble corn fiberOTHER

soluble corn fiber

Beverage with soluble corn fiberSnack with soluble corn fiber
maltodextrinOTHER

maltodextrin

Beverage with maltodextrinSnack with maltodextrin

Eligibility Criteria

Age21 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailshealthy male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese male subjects aged between 21 and 60 years
  • Either one of the three criteria:
  • Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
  • Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L
  • Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose \<5.0mmol/L

You may not qualify if:

  • Do smoke
  • Have any metabolic diseases (such as diabetes, hypertension etc)
  • Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
  • Have medical conditions and/or taking medications known to affect glycemia (glucocorticoids, thyroid hormones, thiazide diuretics)
  • Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug
  • Consume fiber supplements or other supplements that is likely to interfere with study outcomes
  • Have any severe food allergy (e.g. anaphylaxis to peanuts)
  • Have any known allergies to any food components of the study protocol
  • Have active Tuberculosis (TB) or currently receiving treatment for TB
  • Have any 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)
  • Is a study team member or an immediate family of any study team member. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Is enrolled in a concurrent research study judged not to be scientifically or medically compatible with the study of the CNRC.
  • Partake in sports at the competitive and/or endurance levels
  • Intentionally restrict food intake
  • Have poor veins impeding venous access
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Glucose IntoleranceObesity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Participant
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: randomized
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 12, 2017

Study Start

August 25, 2017

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)