Clinical trial NCT02701270: Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Glycemic Index
Dietary Fiber
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Secondary outcomes:
measure: Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
timeFrame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food Research
Study officials:
References:
citation: Hasselwander O, DiCosimo R, You Z, Cheng Q, Rothman SC, Suwannakham S, Baer ZC, Roesch BM, Ruebling-Jass KD, Lai JP, Hurteau RE, Marquez ML, Kopatsis AD, Ouwehand AC, Forssten SD, Mukerji P, Caverly Rae JM, Dragan YP, Damewood JR, Tiihonen K, Ibarra A. Development of dietary soluble fibres by enzymatic synthesis and assessment of their digestibility in in vitro, animal and randomised clinical trial models. Int J Food Sci Nutr. 2017 Nov;68(7):849-864. doi: 10.1080/09637486.2017.1295027. Epub 2017 Mar 1.