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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Dietary Fibre 1 | Experimental |
| |
| Experimental Dietary Fibre 2 | Experimental |
| |
| Polydextrose | Active Comparator |
| |
| Dextrose control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Dietary Fibre 1 | Dietary Supplement | 22.17 g of product diluted in 250 ml of water taken once orally. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leatherhead Food Research | Leatherhead | KT22 7RY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28276900 | Derived | 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. |
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13 healthy volunteers were recruited, 12 volunteers were screened and one excluded (did not meet inclusion criteria).
Volunteers were recruited through the Study site (Leatherhead Food Research, UK) volunteer database in September - October 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polydextrose First, Then Dextrose, Fibre1 and Fibre 2 | Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2. |
| FG001 | Dextrose First, Then Fibre1, Fibre 2 and Polydextrose | Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control. |
| FG002 | Fibre1 First, Then Fibre 2, Polydextrose and Dextrose | Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control. |
| FG003 | Fibre 2 First, Then Polydextrose, Dextrose and Fibre1 | Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention at Visit 1 |
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| Second Intervention at Visit 2 |
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| Third Intervention at Visit 3 |
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| Fourth Intervention at Visit 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response | Participants from whom full set of blood glucose measurements were available. | Posted | Mean | Standard Deviation | min*mmol/L | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Dietary Fibre 1 | Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsti Tiihonen | Danisco Sweeteners Oy | +358 10 431 050 | kirsti.tiihonen@dupont.com |
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| ID | Term |
|---|---|
| C033375 | polydextrose |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Experimental Dietary Fibre 2 | Dietary Supplement | 21.84 g of product diluted in 250 ml of water taken once orally. |
|
| Polydextrose | Dietary Supplement | 21.48 g of product diluted in 250 ml of water taken once orally. |
|
| Dextrose | Dietary Supplement | 23.89 g of dextrose diluted in 250 ml of water taken once orally. |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Polydextrose Control |
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally. |
| OG003 | Dextrose Control | Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally. |
|
|
| Secondary | Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response | Participants from whom full set of blood insulin measurements were available. | Posted | Mean | Standard Deviation | min*mmol/L | 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose |
|
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Experimental Dietary Fibre 2 | Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally. | 0 | 11 | 2 | 11 |
| EG002 | Polydextrose Control | Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally. | 0 | 11 | 0 | 11 |
| EG003 | Dextrose Control | Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally. | 0 | 11 | 0 | 11 |
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