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

Overview

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

Full Title of Study: “Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2012

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Control Product
    • 200 ml water with 50g of sucrose
  • Active Comparator: Product 1
    • 200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine

Clinical Trial Outcome Measures

Primary Measures

  • Glycaemic response to sucrose
    • Time Frame: 0-180 minutes

Secondary Measures

  • Insulin in venous plasma
    • Time Frame: 0-180 minutes

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bioglane
  • Collaborator
    • University Rovira i Virgili
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rosa Solà, PhD MD, Principal Investigator, University Rovira i Virgili

References

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.

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