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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701270
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Danisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Experimental Dietary Fibre 1 Dietary Supplement: Experimental Dietary Fibre 2 Dietary Supplement: Polydextrose Dietary Supplement: Dextrose Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Dietary Fibre 1 Dietary Supplement: Experimental Dietary Fibre 1
22.17 g of product diluted in 250 ml of water taken once orally.
Experimental: Experimental Dietary Fibre 2 Dietary Supplement: Experimental Dietary Fibre 2
21.84 g of product diluted in 250 ml of water taken once orally.
Active Comparator: Polydextrose Dietary Supplement: Polydextrose
21.48 g of product diluted in 250 ml of water taken once orally.
Active Comparator: Dextrose control Dietary Supplement: Dextrose
23.89 g of dextrose diluted in 250 ml of water taken once orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701270


Locations
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United Kingdom
Leatherhead Food Research
Leatherhead, United Kingdom, KT22 7RY
Sponsors and Collaborators
Danisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT02701270    
Other Study ID Numbers: 111031-DP-2015-06-26
First Posted: March 8, 2016    Key Record Dates
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Danisco:
Glycemic Index
Dietary Fiber