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

Not Applicable

Completed

• Conditions: Glycaemic Response; Insulinemic Response
• Interventions: Other: D-Fagomine

• Registration Number: NCT01528631
• Lead Sponsor: Bioglane

Brief Summary

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Product	D-Fagomine	200 ml water with 50g of sucrose
Product 1	D-Fagomine	200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine

Primary Outcome Measures

Name	Time	Method
Glycaemic response to sucrose	0-180 minutes

Secondary Outcome Measures

Name	Time	Method
Insulin in venous plasma	0-180 minutes

Trial Locations

Locations (1)

Hospital Universitari Sant Joan, Universitat Rovira i Virgili; 🇪🇸 Reus, Tarragona, Spain