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

Glycaemic Response Clinical Trial

Official title:

Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528631
• Other study ID #: 1AP029010911
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: July 24, 2012
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Bioglane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glycaemic Response
• Insulinemic Response

Intervention

Other:
• D-Fagomine
30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.
• D-Fagomine
0 mg (control) blended with 50 grams of sucrose in 200 ml of water.

Locations

Country	Name	City	State
Spain	Hospital Universitari Sant Joan, Universitat Rovira i Virgili	Reus	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
Bioglane	National Research Council, Spain, Technological Centre of Nutrition and Health, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Gómez L, Molinar-Toribio E, Calvo-Torras MÁ, Adelantado C, Juan ME, Planas JM, Cañas X, Lozano C, Pumarola S, Clapés 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic response to sucrose		0-180 minutes	No
Secondary	Insulin in venous plasma		0-180 minutes	No

External Links

•   BIOGLANE SLNE
•   CTNS - Technology Centre of Nutrition and Health
•   D-Fagomine
•   URV - Rovira i Virgili University