NCT01528631

Brief Summary

The aim of this study is to evaluate the effect of D-fagomine on glycaemic response to sucrose in men.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

February 3, 2012

Last Update Submit

July 24, 2012

Conditions

Glycaemic ResponseInsulinemic Response

Outcome Measures

Primary Outcomes (1)

  • Glycaemic response to sucrose

    0-180 minutes

Secondary Outcomes (1)

  • Insulin in venous plasma

    0-180 minutes

Study Arms (2)

Control Product

PLACEBO COMPARATOR

200 ml water with 50g of sucrose

Other: D-Fagomine

Product 1

ACTIVE COMPARATOR

200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine

Other: D-Fagomine

Interventions

D-FagomineOTHER

30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.

Product 1

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Males between the ages of 20 and 70 willing and able to provide written informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, 43204, Spain

Location

Related Publications (1)

  • Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes 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.

    PMID: 22017795BACKGROUND

Related Links

MeSH Terms

Interventions

fagomine

Study Officials

  • Rosa Solà, PhD MD

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

July 25, 2012

Record last verified: 2012-07

Locations

ES(1)