The Effects of D-Fagomine on Glycaemic Response to Sucrose in Men

NCT ID: NCT01528631

Last Updated: 2012-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-06-30

Brief Summary

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The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.

Detailed Description

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To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.

Conditions

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Glycaemic Response Insulinemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Product

200 ml water with 50g of sucrose

Group Type PLACEBO_COMPARATOR

D-Fagomine

Intervention Type OTHER

0 mg (control) blended with 50 grams of sucrose in 200 ml of water.

Product 1

200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine

Group Type ACTIVE_COMPARATOR

D-Fagomine

Intervention Type OTHER

30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.

Interventions

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D-Fagomine

30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.

Intervention Type OTHER

D-Fagomine

0 mg (control) blended with 50 grams of sucrose in 200 ml of water.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1\. Males between the ages of 20 and 70 willing and able to provide written informed consent.

Exclusion Criteria

1. LDL cholesterol levels higher than 189 mg/dl
2. Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
3. Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
4. Consumption of supplements or acetylsalicylic acid
5. Chronic alcoholism
6. Body mass index (BMI) greater than 30 kg/m2
7. Previous antihypertensive treatment at the start of the trial that has not finished at least 2 months before beginning the study
8. Diabetes mellitus (if the fasting blood glucose is higher than 126 mg/dl, the test should be repeated and confirmed)
9. Kidney disease (serum creatine levels above 1,4 mg/dl for women and above 1,5 mg/dl for men)
10. Acute infectious diseases, malignant tumors, severe liver failure, respiratory failure associated with chronic or endocrine diseases
11. Other conditions such as special dietary needs
12. To be participating or having participated in a clinical trial within the last 3 months
13. Inability to continue the study
14. History of gastrointestinal disease which may alter the absorption of nutrients
15. Depressive disorder or thoughts of self-injury
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Rovira i Virgili

OTHER

Sponsor Role collaborator

Technological Centre of Nutrition and Health

OTHER

Sponsor Role collaborator

National Research Council, Spain

OTHER_GOV

Sponsor Role collaborator

Bioglane

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa SolĂ , PhD MD

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

Locations

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Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 22017795 (View on PubMed)

Related Links

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http://www.ctns.cat

CTNS - Technology Centre of Nutrition and Health

http://www.urv.cat

URV - Rovira i Virgili University

Other Identifiers

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1AP029010911

Identifier Type: -

Identifier Source: org_study_id