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

This study has been completed.
University Rovira i Virgili
Technological Centre of Nutrition and Health
National Research Council, Spain
Information provided by (Responsible Party):
Bioglane Identifier:
First received: February 3, 2012
Last updated: July 24, 2012
Last verified: July 2012
The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.

Condition Intervention
Glycaemic Response
Insulinemic Response
Other: D-Fagomine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men

Resource links provided by NLM:

Further study details as provided by Bioglane:

Primary Outcome Measures:
  • Glycaemic response to sucrose [ Time Frame: 0-180 minutes ]

Secondary Outcome Measures:
  • Insulin in venous plasma [ Time Frame: 0-180 minutes ]

Enrollment: 12
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Product
200 ml water with 50g of sucrose
Other: D-Fagomine
0 mg (control) blended with 50 grams of sucrose in 200 ml of water.
Active Comparator: Product 1
200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine
Other: D-Fagomine
30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.

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

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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
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Please refer to this study by its identifier: NCT01528631

Hospital Universitari Sant Joan, Universitat Rovira i Virgili
Reus, Tarragona, Spain, 43204
Sponsors and Collaborators
University Rovira i Virgili
Technological Centre of Nutrition and Health
National Research Council, Spain
Principal Investigator: Rosa Solà, PhD MD University Rovira i Virgili
  More Information