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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701270
• Other study ID #: 111031-DP-2015-06-26
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: March 2, 2016
• Start date: September 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Experimental Dietary Fibre 1
22.17 g of product diluted in 250 ml of water taken once orally.
• Experimental Dietary Fibre 2
21.84 g of product diluted in 250 ml of water taken once orally.
• Polydextrose
21.48 g of product diluted in 250 ml of water taken once orally.
• Dextrose
23.89 g of dextrose diluted in 250 ml of water taken once orally.

Locations

Country	Name	City	State
United Kingdom	Leatherhead Food Research	Leatherhead

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of IAUC (incremental area under the curve) in blood glucose response		After 4 hours following study product intake	No
Secondary	Assessment of IAUC (incremental area under the curve) in blood insulin response		After 4 hours following study product intake	No