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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
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by Bioglane:

Primary Outcome Measures:
  • Glycaemic response to sucrose [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin in venous plasma [ Time Frame: 0-180 minutes ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528631

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

Additional Information:
BIOGLANE SLNE  This link exits the ClinicalTrials.gov site
D-Fagomine  This link exits the ClinicalTrials.gov site
CTNS - Technology Centre of Nutrition and Health  This link exits the ClinicalTrials.gov site
URV - Rovira i Virgili University  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Bioglane
ClinicalTrials.gov Identifier: NCT01528631     History of Changes
Other Study ID Numbers: 1AP029010911
Study First Received: February 3, 2012
Last Updated: July 24, 2012
Health Authority: Spain: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013