Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men
| Registry | NCT01528631 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, basic science |
| Enrollment | 12 (Actual) |
| Sponsor | Bioglane (Industry); collaborators: University Rovira i Virgili, Technological Centre of Nutrition and Health, National Research Council, Spain |
| Conditions | Glycaemic Response, Insulinemic Response |
| Interventions | D-Fagomine (Other) |
| Dates | start 2012-02-01, primary completion 2012-05-01, completion 2012-06-01, first posted 2012-02-08, last updated 2012-07-25 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Glycaemic Response All trials for Insulinemic Response All trials of D-Fagomine
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.
To determine and compare glycaemic response to sucrose of D-Fagomine and control in the timeframe of 180 minutes.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Product | Placebo comparator | Other: D-Fagomine | 200 ml water with 50g of sucrose |
| Product 1 | Active comparator | Other: D-Fagomine | 200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine |
Sex: Male, ages: 20 Years to 70 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitari Sant Joan, Universitat Rovira i Virgili | Reus, Tarragona | Spain |