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Completed

NCT Number: NCT02701270

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leatherhead Food Research

Leatherhead, KT22 7RY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental Dietary Fibre 1

Dietary Supplement

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

Experimental Dietary Fibre 2

Dietary Supplement

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

Polydextrose

Dietary Supplement

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

DEXTROSE

Dietary Supplement

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

Primary outcomes

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study title

Randomised, Single-blinded, Controlled, Crossover and Acute Clinical Intervention to Assess the Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2016
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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