Reduction of Post-prandial Glycaemic ResponseNCT01811303

Effects of Added D-fagomine on Glycaemic Responses to Sucrose

A study testing D-fagomine in people with Reduction of Post-prandial Glycaemic Response, run by Bioglane 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 D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Reduction of Post-prandial Glycaemic Response
What is being tested?: D-fagomine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2012to Mar 2013
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female (not less than 40% Male)
Aged 18 - 55 years
Have a body mass index between 18.5 to 29.99 kg/m2
Healthy, non-diabetic, no gastric bypass surgery
Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L)
Willing and able to provide written informed consent

Who cannot join

Smokers
Allergic to dairy or soy

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Reading Scientific Services Ltd.
Reading, RG6 6LA

Other trials in United Kingdom

About this study

The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

Read the detailed description

This is a two treatment randomized double-blind crossover study, with each test product replicated twice.

Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.

Washout: 2 days or more (may return on day 3)

Run-in: High carbohydrate diet guidance (>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)

Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)

Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.

Conditions: Reduction of Post-prandial Glycaemic Response
Being tested: D-fagomine

What participants receive

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

D-fagomineOther
Measure the changes produced on the postprandial Glycaemic response

Study groups in NCT01811303
Study group	Role	What they receive
D-fagomine	Experimental	Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water Receives: Other: D-fagomine
Control	Placebo comparator	Sucrose 50 g without d-fagomine, in 200 ml water Receives: Other: D-fagomine

What is being measured

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

Postprandial Glycaemic Response Index
On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.
Measured: 120 minutes

Secondary outcomes (1)

Maximum Blood Glucose Concentration (C Max) Over the Baseline
Determine the glucose C max of Sucrose with D-fagomine over the baseline.
The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.
Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)
Measured: Usually in the range of 30-45 minutes

Timeline

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

Sep 2012Mar 2013

First posted14 Mar 2013 (estimated)
Study startSep 2012
Primary completionMar 2013
Study completionMar 2013

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 (2)Papers the sponsor has linked to this study.
Other trials for Reduction of Post-prandial Glycaemic ResponseStudies 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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01811303
Sponsor's protocol ID: RSSL SSID P12-06545
Status last verified: Aug 2023
First submitted: 12 Mar 2013
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes P, Torres JL. D-Fagomine lowers postprandial blood glucose and modulates bacterial adhesion. Br J Nutr. 2012 Jun;107(12):1739-46. doi: 10.1017/S0007114511005009. Epub 2011 Oct 3.
PubMed 22017795
Amezqueta S, Galan E, Vila-Fernandez I, Pumarola S, Carrascal M, Abian J, Ribas-Barba L, Serra-Majem L, Torres JL. The presence of D-fagomine in the human diet from buckwheat-based foodstuffs. Food Chem. 2013 Feb 15;136(3-4):1316-21. doi: 10.1016/j.foodchem.2012.09.038. Epub 2012 Sep 18.
PubMed 23194529

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Added D-fagomine on Glycaemic Responses to Sucrose
ClinicalTrials.gov ID: NCT01811303
Acronym / sponsor ID: RSSL SSID P12-06545
Conditions: Reduction of Post-prandial Glycaemic Response
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: BioglaneIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 14 Mar 2013 (estimated)
Results: Posted 2 Jul 2013

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 D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

Detailed description

This is a two treatment randomized double-blind crossover study, with each test product replicated twice.

Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.

Washout: 2 days or more (may return on day 3)

Run-in: High carbohydrate diet guidance (>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)

Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)

Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
D-fagomine	Experimental	Other: D-fagomineMeasure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water
Control	Placebo comparator	Other: D-fagomineSucrose 50 g without d-fagomine, in 200 ml water

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male or female (not less than 40% Male)
Aged 18 - 55 years
Have a body mass index between 18.5 to 29.99 kg/m2
Healthy, non-diabetic, no gastric bypass surgery
Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L)

Key exclusion criteria (2 listed)

Smokers
Allergic to dairy or soy

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
D-fagomineMeasure the changes produced on the postprandial Glycaemic response	Other	Control, D-fagomine

Primary outcome

Postprandial Glycaemic Response Index
Time frame: 120 minutes
On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.

1 secondary outcome

Maximum Blood Glucose Concentration (C Max) Over the Baseline
Time frame: Usually in the range of 30-45 minutes

Results and safety

Results posted to the registry on 2 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Placebo, Treatment, Treatment	4	4
Treatment, Treatment, Placebo, Placebo	4	4
Placebo, Treatment, Placebo, Treatment	4	4
Treatment, Placebo, Treatment, Placebo	2	2

Primary outcome: Postprandial Glycaemic Response Index

Time frame: 120 minutes. Mean (95% Confidence Interval). Unit: percentage of AUC fagomine/AUC control

Measure	Change D-fagomine/Control AUC at 60 Min n = 14	Change D-fagomine/Control AUC at 120 Min n = 14
Value	73.28 (63.66 to 82.90)	83.45 (67.73 to 99.17)

Change D-fagomine/Control AUC at 60 Min: p <0.0001, ANOVA
Change D-fagomine/Control AUC at 120 Min: p <0.016, ANOVA

Population analysed: The number of participants \>10, the repetitions \>= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145-171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.

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
D-fagomine (All Study Participants)	0 of 14 (0%)	0 of 14 (0%)	Not reported
Placebo - Control (All Study Participants)	0 of 14 (0%)	0 of 14 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22017795Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes P, Torres JL. D-Fagomine lowers postprandial blood glucose and modulates bacterial adhesion. Br J Nutr. 2012 Jun;107(12):1739-46. doi: 10.1017/S0007114511005009. Epub 2011 Oct 3.
Background: PubMed 23194529Amezqueta S, Galan E, Vila-Fernandez I, Pumarola S, Carrascal M, Abian J, Ribas-Barba L, Serra-Majem L, Torres JL. The presence of D-fagomine in the human diet from buckwheat-based foodstuffs. Food Chem. 2013 Feb 15;136(3-4):1316-21. doi: 10.1016/j.foodchem.2012.09.038. Epub 2012 Sep 18.

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.

Rungano Munyuki principal investigator

Reading Scientific Services Ltd.

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

Questions about this trial

What is this clinical trial studying?

A study testing D-fagomine in people with Reduction of Post-prandial Glycaemic Response, run by Bioglane 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 6 inclusion and 2 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 18 Sep 2023. 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. Some participants in this study may receive a placebo. 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 2 Jul 2013). 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?

Postprandial Glycaemic Response Index (time frame: 120 minutes). 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 NCT01811303, which also lists 2 linked publications.

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 18 Sep 2023.