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

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ClinicalTrials.gov Identifier: NCT01528631
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : July 25, 2012
Sponsor:
Collaborators:
University Rovira i Virgili
Technological Centre of Nutrition and Health
National Research Council, Spain
Information provided by (Responsible Party):
Bioglane

Tracking Information
First Submitted Date  ICMJE February 3, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date July 25, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Glycaemic response to sucrose [ Time Frame: 0-180 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01528631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Insulin in venous plasma [ Time Frame: 0-180 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of D-Fagomine on Glycaemic Response to Sucrose in Men
Official Title  ICMJE Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Glycaemic Response
  • Insulinemic Response
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528631
Other Study ID Numbers  ICMJE 1AP029010911
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bioglane
Study Sponsor  ICMJE Bioglane
Collaborators  ICMJE
  • University Rovira i Virgili
  • Technological Centre of Nutrition and Health
  • National Research Council, Spain
Investigators  ICMJE
Principal Investigator: Rosa Solà, PhD MD University Rovira i Virgili
PRS Account Bioglane
Verification Date July 2012

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