NCT02701270

Brief Summary

The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products 1 and 2 are digested using glycaemic and insulinaemic response as markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable healthy-volunteers

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

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 27, 2016

Completed
Last Updated

July 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

February 25, 2016

Results QC Date

April 12, 2016

Last Update Submit

June 16, 2016

Conditions

Healthy Volunteers

Keywords

Glycemic IndexDietary Fiber

Outcome Measures

Primary Outcomes (1)

  • Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Secondary Outcomes (1)

  • Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response

    0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Study Arms (4)

Experimental Dietary Fibre 1

EXPERIMENTAL
Dietary Supplement: Experimental Dietary Fibre 1

Experimental Dietary Fibre 2

EXPERIMENTAL
Dietary Supplement: Experimental Dietary Fibre 2

Polydextrose

ACTIVE COMPARATOR
Dietary Supplement: Polydextrose

Dextrose control

ACTIVE COMPARATOR
Dietary Supplement: Dextrose

Interventions

Experimental Dietary Fibre 1DIETARY_SUPPLEMENT

22.17 g of product diluted in 250 ml of water taken once orally.

Experimental Dietary Fibre 1
Experimental Dietary Fibre 2DIETARY_SUPPLEMENT

21.84 g of product diluted in 250 ml of water taken once orally.

Experimental Dietary Fibre 2
PolydextroseDIETARY_SUPPLEMENT

21.48 g of product diluted in 250 ml of water taken once orally.

Polydextrose
DextroseDIETARY_SUPPLEMENT

23.89 g of dextrose diluted in 250 ml of water taken once orally.

Dextrose control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 18-27 kg/m2.
  • Self-diagnosed as healthy at the time of recruitment, confirmed by medical questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders.
  • No blood donations during the study.
  • Reported intense sporting activities \< 10hr/w.
  • Reported alcohol consumption ≤21 units/w (female volunteers) or ≤28 units/w (male volunteers).
  • Feasibility to give blood sample as per study protocol.
  • Informed consent signed

You may not qualify if:

  • Dislike, allergy or intolerance to test products.
  • Fasting blood glucose levels \<4.4 or \>6.1.
  • Volunteer has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator.
  • Volunteer with history of diabetes and high blood pressure.
  • Having consumed anything apart from plain water in the twelve hours prior to the first test day.
  • Volunteer and/or immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization.
  • Reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 3 months ago) or wish to become pregnant during the study.
  • Reported participation in another biomedical trial 1 month before the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leatherhead Food Research

Leatherhead, KT22 7RY, United Kingdom

Location

Related Publications (1)

  • Hasselwander O, DiCosimo R, You Z, Cheng Q, Rothman SC, Suwannakham S, Baer ZC, Roesch BM, Ruebling-Jass KD, Lai JP, Hurteau RE, Marquez ML, Kopatsis AD, Ouwehand AC, Forssten SD, Mukerji P, Caverly Rae JM, Dragan YP, Damewood JR, Tiihonen K, Ibarra A. Development of dietary soluble fibres by enzymatic synthesis and assessment of their digestibility in in vitro, animal and randomised clinical trial models. Int J Food Sci Nutr. 2017 Nov;68(7):849-864. doi: 10.1080/09637486.2017.1295027. Epub 2017 Mar 1.

    PMID: 28276900DERIVED

MeSH Terms

Interventions

polydextroseGlucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Results Point of Contact

Title
Kirsti Tiihonen
Organization
Danisco Sweeteners Oy
kirsti.tiihonen@dupont.com
+358 10 431 050

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 8, 2016

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 27, 2016

Results First Posted

July 27, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)