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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01528631
Enrollment
12
Registered
2012-02-08
Start date
2012-02-29
Completion date
2012-06-30
Last updated
2012-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycaemic Response, Insulinemic Response

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.

Interventions

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

Sponsors

University Rovira i Virgili
CollaboratorOTHER
Technological Centre of Nutrition and Health
CollaboratorOTHER
National Research Council, Spain
CollaboratorOTHER_GOV
Bioglane
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Glycaemic response to sucrose0-180 minutes

Secondary

MeasureTime frame
Insulin in venous plasma0-180 minutes

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026