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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Experimental Dietary Fibre 1
* Dietary Supplement: Experimental Dietary Fibre 2
* Dietary Supplement: Polydextrose
* Dietary Supplement: Dextrose


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Dietary Fibre 1<br> | Dietary Supplement: Experimental Dietary Fibre 1<br>* 22.17 g of product diluted in 250 ml of water taken once orally.<br>|
| Experimental: Experimental Dietary Fibre 2<br> | Dietary Supplement: Experimental Dietary Fibre 2<br>* 21.84 g of product diluted in 250 ml of water taken once orally.<br>|
| Active Comparator: Polydextrose<br> | Dietary Supplement: Polydextrose<br>* 21.48 g of product diluted in 250 ml of water taken once orally.<br>|
| Active Comparator: Dextrose control<br> | Dietary Supplement: Dextrose<br>* 23.89 g of dextrose diluted in 250 ml of water taken once orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Index, Dietary Fiber