Healthy Volunteers
Conditions
Keywords
Glycemic Index, Dietary Fiber
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.
Interventions
DIETARY_SUPPLEMENTExperimental Dietary Fibre 1
22.17 g of product diluted in 250 ml of water taken once orally.
DIETARY_SUPPLEMENTExperimental Dietary Fibre 2
21.84 g of product diluted in 250 ml of water taken once orally.
DIETARY_SUPPLEMENTPolydextrose
21.48 g of product diluted in 250 ml of water taken once orally.
DIETARY_SUPPLEMENTDextrose
23.89 g of dextrose diluted in 250 ml of water taken once orally.
Sponsors
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United Kingdom
Participant flow
Recruitment details
Volunteers were recruited through the Study site (Leatherhead Food Research, UK) volunteer database in September - October 2015.
Pre-assignment details
13 healthy volunteers were recruited, 12 volunteers were screened and one excluded (did not meet inclusion criteria).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 44.09 years STANDARD_DEVIATION 2.56 |
| Body Mass Index | 23.8 kg/m^2 STANDARD_DEVIATION 0.62 |
| Region of Enrollment United Kingdom | 12 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 11 | 2 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Population: Participants from whom full set of blood glucose measurements were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dietary Fibre 1 | Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response | 127.45 min*mmol/L | Standard Deviation 52.24 |
| Experimental Dietary Fibre 2 | Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response | 143.53 min*mmol/L | Standard Deviation 52.11 |
| Polydextrose Control | Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response | 19.27 min*mmol/L | Standard Deviation 8.03 |
| Dextrose Control | Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response | 134.21 min*mmol/L | Standard Deviation 59 |
Secondary
Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
Time frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Population: Participants from whom full set of blood insulin measurements were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Dietary Fibre 1 | Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response | 595.49 min*mmol/L | Standard Deviation 151.72 |
| Experimental Dietary Fibre 2 | Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response | 640.94 min*mmol/L | Standard Deviation 286.52 |
| Polydextrose Control | Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response | 63.37 min*mmol/L | Standard Deviation 55.81 |
| Dextrose Control | Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response | 687.13 min*mmol/L | Standard Deviation 257.67 |