N/A
N=11
Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02701270 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response — 127.45; 143.53; 19.27; 134.21 min*mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Dietary Fibre 1 (Dietary_supplement); Experimental Dietary Fibre 2 (Dietary_supplement); Polydextrose (Dietary_supplement); Dextrose (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Danisco
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response |
127.45; 143.53; 19.27; 134.21 | — |
| SECONDARY Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response |
595.49; 640.94; 63.37; 687.13 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT02701270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.