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

July 24, 2012 updated by: Bioglane

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Product
200 ml water with 50g of sucrose
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.
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.
Other: D-Fagomine
0 mg (control) blended with 50 grams of sucrose in 200 ml of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycaemic response to sucrose
Time Frame: 0-180 minutes
0-180 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin in venous plasma
Time Frame: 0-180 minutes
0-180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioglane

Collaborators

University Rovira i Virgili
National Research Council, Spain
Technological Centre of Nutrition and Health

Investigators

  • Principal Investigator: Rosa Solà, PhD MD, University Rovira i Virgili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (ESTIMATE)

February 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 1AP029010911

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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