Healthy VolunteersNCT02701270

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

A study testing Experimental Dietary Fibre 1, Experimental Dietary Fibre 2 and Polydextrose in people with Healthy Volunteers, run by Danisco at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Experimental Dietary Fibre 1, Experimental Dietary Fibre 2 and Polydextrose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2015to Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Leatherhead Food Research
Leatherhead, KT22 7RY

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions: Healthy Volunteers
Being tested: Experimental Dietary Fibre 1, Experimental Dietary Fibre 2, Polydextrose, Dextrose
Keywords: Glycemic Index, Dietary Fiber

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Dietary Fibre 1Dietary supplement
22.17 g of product diluted in 250 ml of water taken once orally.
Experimental Dietary Fibre 2Dietary supplement
21.84 g of product diluted in 250 ml of water taken once orally.
PolydextroseDietary supplement
21.48 g of product diluted in 250 ml of water taken once orally.
DextroseDietary supplement
23.89 g of dextrose diluted in 250 ml of water taken once orally.

Study groups in NCT02701270
Study group	Role	What they receive
Experimental Dietary Fibre 1	Experimental	Not described Receives: Dietary Supplement: Experimental Dietary Fibre 1
Experimental Dietary Fibre 2	Experimental	Not described Receives: Dietary Supplement: Experimental Dietary Fibre 2
Polydextrose	Active comparator	Not described Receives: Dietary Supplement: Polydextrose
Dextrose control	Active comparator	Not described Receives: Dietary Supplement: Dextrose

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Secondary outcomes (1)

Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Oct 2015

First posted8 Mar 2016 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02701270
Sponsor's protocol ID: 111031-DP-2015-06-26
Status last verified: Jun 2016
First submitted: 25 Feb 2016
Last updated: 27 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28276900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02701270
Acronym / sponsor ID: 111031-DP-2015-06-26
Conditions: Healthy Volunteers
Keywords: Glycemic Index, Dietary Fiber
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: DaniscoIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 8 Mar 2016 (estimated)
Results: Posted 27 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Experimental Dietary Fibre 1	Experimental	Dietary Supplement: Experimental Dietary Fibre 1
Experimental Dietary Fibre 2	Experimental	Dietary Supplement: Experimental Dietary Fibre 2
Polydextrose	Active comparator	Dietary Supplement: Polydextrose
Dextrose control	Active comparator	Dietary Supplement: Dextrose

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Experimental Dietary Fibre 122.17 g of product diluted in 250 ml of water taken once orally.	Dietary supplement	Experimental Dietary Fibre 1
Experimental Dietary Fibre 221.84 g of product diluted in 250 ml of water taken once orally.	Dietary supplement	Experimental Dietary Fibre 2
Polydextrose21.48 g of product diluted in 250 ml of water taken once orally.	Dietary supplement	Polydextrose
Dextrose23.89 g of dextrose diluted in 250 ml of water taken once orally.	Dietary supplement	Dextrose control

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 27 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Polydextrose First, Then Dextrose, Fibre1 and Fibre 2	2	2
Dextrose First, Then Fibre1, Fibre 2 and Polydextrose	3	3
Fibre1 First, Then Fibre 2, Polydextrose and Dextrose	3	3
Fibre 2 First, Then Polydextrose, Dextrose and Fibre1	3	3

Primary outcome: 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. Mean (Standard Deviation). Unit: min*mmol/L

Measure	Experimental Dietary Fibre 1 n = 11	Experimental Dietary Fibre 2 n = 11	Polydextrose Control n = 11	Dextrose Control n = 11
Value	127.45 (52.24)	143.53 (52.11)	19.27 (8.03)	134.21 (59.00)

Population analysed: Participants from whom full set of blood glucose measurements were available.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Dietary Fibre 1	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Experimental Dietary Fibre 2	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Polydextrose Control	0 of 11 (0%)	0 of 11 (0%)	Not reported
Dextrose Control	0 of 11 (0%)	0 of 11 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28276900Hasselwander 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Dietary Fibre 1, Experimental Dietary Fibre 2 and Polydextrose in people with Healthy Volunteers, run by Danisco at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02701270, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.