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

D

Danisco

Status

Completed

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Polydextrose
Dietary Supplement: Dextrose
Dietary Supplement: Experimental Dietary Fibre 2
Dietary Supplement: Experimental Dietary Fibre 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT02701270
111031-DP-2015-06-26

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

13 participants in 4 patient groups

Experimental Dietary Fibre 1
Experimental group
Treatment:
Dietary Supplement: Experimental Dietary Fibre 1
Experimental Dietary Fibre 2
Experimental group
Treatment:
Dietary Supplement: Experimental Dietary Fibre 2
Polydextrose
Active Comparator group
Treatment:
Dietary Supplement: Polydextrose
Dextrose control
Active Comparator group
Treatment:
Dietary Supplement: Dextrose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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