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Completed

NCT Number: NCT01528631

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.

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Key information

Conditions

Glycaemic Response Insulinemic Response

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, 43204, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

D-Fagomine

Other

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

Primary outcomes

  1. Glycaemic response to sucrose

    Time frame: 0-180 minutes

Secondary outcomes

  1. Insulin in venous plasma

    Time frame: 0-180 minutes

Sponsors and collaborators

Lead sponsor

Bioglane

Industry

Collaborators

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

Registry information

Official study title

Randomized Controlled Double-blind Nutritional Intervention Trial to Evaluate the Effects of D-fagomine on Glycaemic Response to Sucrose in Men

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Jul 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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