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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Experimental Dietary Fibre 1; Dietary Supplement: Dextrose; Dietary Supplement: Experimental Dietary Fibre 2; Dietary Supplement: Polydextrose

• Registration Number: NCT02701270
• Lead Sponsor: Danisco

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.

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Results First Submitted: 2016-04-12
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Results First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Dietary Fibre 1	Experimental Dietary Fibre 1	-
Dextrose control	Dextrose	-
Experimental Dietary Fibre 2	Experimental Dietary Fibre 2	-
Polydextrose	Polydextrose	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Leatherhead Food Research; 🇬🇧 Leatherhead, United Kingdom