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

This study has been completed.
Sponsor:
Collaborators:
University Rovira i Virgili
Technological Centre of Nutrition and Health
National Research Council, Spain
Information provided by (Responsible Party):
Bioglane
ClinicalTrials.gov Identifier:
NCT01528631
First received: February 3, 2012
Last updated: July 24, 2012
Last verified: July 2012

February 3, 2012
July 24, 2012
February 2012
May 2012   (final data collection date for primary outcome measure)
Glycaemic response to sucrose [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01528631 on ClinicalTrials.gov Archive Site
Insulin in venous plasma [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Glycaemic Response
  • Insulinemic Response
  • 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.
  • Placebo Comparator: Control Product
    200 ml water with 50g of sucrose
    Intervention: Other: D-Fagomine
  • Active Comparator: Product 1
    200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine
    Intervention: Other: D-Fagomine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Male
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01528631
1AP029010911
No
Bioglane
Bioglane
  • University Rovira i Virgili
  • Technological Centre of Nutrition and Health
  • National Research Council, Spain
Principal Investigator: Rosa Solà, PhD MD University Rovira i Virgili
Bioglane
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP