Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

NCT ID: NCT02701270

Last Updated: 2016-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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DuPont Experimental Dietary Fibre products 1 and 2 glycaemic and insulinaemic response will be compared against that of polydextrose and dextrose when given to adult healthy volunteers.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Dietary Fibre 1

Group Type EXPERIMENTAL

Experimental Dietary Fibre 1

Intervention Type DIETARY_SUPPLEMENT

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

Experimental Dietary Fibre 2

Group Type EXPERIMENTAL

Experimental Dietary Fibre 2

Intervention Type DIETARY_SUPPLEMENT

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

Polydextrose

Group Type ACTIVE_COMPARATOR

Polydextrose

Intervention Type DIETARY_SUPPLEMENT

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

Dextrose control

Group Type ACTIVE_COMPARATOR

Dextrose

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Experimental Dietary Fibre 1

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

Intervention Type DIETARY_SUPPLEMENT

Experimental Dietary Fibre 2

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

Intervention Type DIETARY_SUPPLEMENT

Polydextrose

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

Intervention Type DIETARY_SUPPLEMENT

Dextrose

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Leatherhead Food Research

Leatherhead, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 28276900 (View on PubMed)

Other Identifiers

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111031-DP-2015-06-26

Identifier Type: -

Identifier Source: org_study_id

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