Glycaemic ResponseNCT01528631
The Effects of D-Fagomine on Glycaemic Response to Sucrose in Men
A study testing D-Fagomine in people with Glycaemic Response and Insulinemic Response, run by Bioglane at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glycaemic Response, Insulinemic Response
- What is being tested?
- D-Fagomine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Males between the ages of 20 and 70 willing and able to provide written informed consent.
Who cannot join
- LDL cholesterol levels higher than 189 mg/dl
- Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
- Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
- Consumption of supplements or acetylsalicylic acid
- Chronic alcoholism
- Body mass index (BMI) greater than 30 kg/m2
Show all 15Show fewer
- Previous antihypertensive treatment at the start of the trial that has not finished at least 2 months before beginning the study
- Diabetes mellitus (if the fasting blood glucose is higher than 126 mg/dl, the test should be repeated and confirmed)
- Kidney disease (serum creatine levels above 1,4 mg/dl for women and above 1,5 mg/dl for men)
- Acute infectious diseases, malignant tumors, severe liver failure, respiratory failure associated with chronic or endocrine diseases
- Other conditions such as special dietary needs
- To be participating or having participated in a clinical trial within the last 3 months
- Inability to continue the study
- History of gastrointestinal disease which may alter the absorption of nutrients
- Depressive disorder or thoughts of self-injury
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Sant Joan, Universitat Rovira i Virgili
Reus, Tarragona, 43204
About this study
Official title: Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.
Read the detailed description
To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.
- Conditions
- Glycaemic Response, Insulinemic 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
30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.
D-FagomineOther
0 mg (control) blended with 50 grams of sucrose in 200 ml of water.
| Study group | Role | What they receive |
|---|---|---|
| Control Product | Placebo comparator | 200 ml water with 50g of sucrose Receives: Other: D-Fagomine |
| Product 1 | Active comparator | 200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine Receives: Other: D-Fagomine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic response to sucrose
Measured: 0-180 minutes
Secondary outcomes (1)
Insulin in venous plasma
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioglane
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Rovira i Virgili, Technological Centre of Nutrition and Health, National Research Council, Spain
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, PhD MD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528631
- Sponsor's protocol ID
- 1AP029010911
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2012
- Last updated
- 25 Jul 2012
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men
- ClinicalTrials.gov ID
- NCT01528631
- Acronym / sponsor ID
- 1AP029010911
- Conditions
- Glycaemic Response, Insulinemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BioglaneIndustry (pharma, biotech, devices)
- Collaborators
- University Rovira i Virgili, Technological Centre of Nutrition and Health, National Research Council, Spain
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.
Detailed description
To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Product | Placebo comparator | Other: D-Fagomine200 ml water with 50g of sucrose |
| Product 1 | Active comparator | Other: D-Fagomine200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Males between the ages of 20 and 70 willing and able to provide written informed consent.
Key exclusion criteria (15 listed)
- LDL cholesterol levels higher than 189 mg/dl
- Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
- Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
- Consumption of supplements or acetylsalicylic acid
- Chronic alcoholism
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-Fagomine30 mg (initial dose), with 50 grams of sucrose in 200 ml of water. | Other | Product 1 |
| D-Fagomine0 mg (control) blended with 50 grams of sucrose in 200 ml of water. | Other | Control Product |
Primary outcome
Glycaemic response to sucrose
Time frame: 0-180 minutes
1 secondary outcome
Insulin in venous plasma
Time frame: 0-180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2012.
- 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.
- BIOGLANE SLNELink provided by the sponsor.
- D-FagomineLink provided by the sponsor.
- CTNS - Technology Centre of Nutrition and HealthLink provided by the sponsor.
- URV - Rovira i Virgili UniversityLink provided by the sponsor.
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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.
Rosa Solà, PhD MD principal investigator
University Rovira i Virgili
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 Glycaemic Response and Insulinemic Response, run by Bioglane at 1 site in Spain.
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 1 inclusion and 15 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 25 Jul 2012. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycaemic response to sucrose (time frame: 0-180 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 NCT01528631, 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 25 Jul 2012.