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

Tracking Information

First Received Date ^ICMJE

February 3, 2012

Last Updated Date

July 24, 2012

Start Date ^ICMJE

February 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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 MA, 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. 2011 Oct 3;:1-8 [Epub ahead of print]

* 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

Enrollment ^ICMJE

Completion Date

June 2012

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:

LDL cholesterol levels higher than 189 mg/dl
Triglycerides higher than 350 mg/dl (the threshold level to determine c-LDL using the Friedewald formula)
Physical examinations and routine biochemical analysis shall be conducted to rule out pathologies.
Consumption of supplements or acetylsalicylic acid
Chronic alcoholism
Body mass index (BMI) greater than 30 kg/m2
Previous antihypertensive treatment at the start of the trial that has not finished at least 2 months before beginning the study
Diabetes mellitus (if the fasting blood glucose is higher than 126 mg/dl, the test should be repeated and confirmed)
Kidney disease (serum creatine levels above 1,4 mg/dl for women and above 1,5 mg/dl for men)
Acute infectious diseases, malignant tumors, severe liver failure, respiratory failure associated with chronic or endocrine diseases
Other conditions such as special dietary needs
To be participating or having participated in a clinical trial within the last 3 months
Inability to continue the study
History of gastrointestinal disease which may alter the absorption of nutrients
Depressive disorder or thoughts of self-injury

Gender

Male

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01528631

Other Study ID Numbers ^ICMJE

1AP029010911

Has Data Monitoring Committee

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

Information Provided By

Bioglane

Verification Date

July 2012

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

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