NCT02831738

Brief Summary

Primary outcome measure: Changes in plasma glucose concentration over a 3 hour postprandial visit after administration of polydextrose (12g) compared to 0 mg placebo. Secondary outcome measure: Changes in gastrointestinal tolerance and acute bowel changes in 3 days following treatment administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable healthy

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

July 2, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

July 11, 2016

Last Update Submit

January 25, 2021

Conditions

Healthy

Keywords

FiberPolydextroseGlycemic Index

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma glucose concentration over a 3 hour Postprandial Test day after administration of Polydextrose (12g) compared to Placebo (0 g)

    plasma glucose concentration over a 3 hour Postprandial Test day

    3 hours

Secondary Outcomes (1)

  • Changes in gastrointestinal tolerance using the questionnaire in 3 days following treatment administrations.

    3 days

Study Arms (2)

Active Treatment

EXPERIMENTAL

Polydextrose 12 g

Dietary Supplement: Polydextrose

Control Treatment

PLACEBO COMPARATOR

No polydextrose

Dietary Supplement: Control Treatment

Interventions

PolydextroseDIETARY_SUPPLEMENT

Polydextrose 12 g

Active Treatment
Control TreatmentDIETARY_SUPPLEMENT

no polydextrose

Control Treatment

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \*Subject is male or female aged between 20 and 55 years of age
  • Subject has BMI between 20.0 and 32.0 kg/m2 at the screening visit
  • Fasting blood sugar less than 126 mg/dL
  • Subject is willing to maintain a stable body weight and to follow his/her regular diet and physical activity patterns throughout the study period.
  • Subject is willing to refrain from vigorous physical activity and consumption of alcoholic and/or caffeinated beverages 24 h prior to each test day
  • Subject does not smoke or has abstained from smoking for at least 2 years
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications or dietary supplements that would interfere with outcomes of the study.
  • Subject typically consumes a low fiber diet that correlates with the average fiber intake of typical western diet.

You may not qualify if:

  • \*Subject currently smokes or has smoked within the past 2 years
  • Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compounds
  • Men and women known to have/diagnosed with diabetes mellitus
  • Men and women with a fasting blood glucose concentration ≥126 mg/dL
  • Average blood pressure \> 140 mmHg/90 mmHg during screening visit
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries
  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years
  • Men and women who are taking medication or dietary supplements that may interfere with the outcomes of the study. Subjects may choose to go off dietary supplements (requires 30 days washout)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Interventions

polydextrose

Study Officials

  • Britt M Burton-Freeman, Ph.D

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 13, 2016

Study Start

July 2, 2016

Primary Completion

August 30, 2016

Study Completion

October 25, 2016

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)