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

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

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

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

Conditions
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Glycaemic Response, Insulinemic Response

Intervention / Treatment
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* Other: D-Fagomine
* Other: D-Fagomine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Product<br>200 ml water with 50g of sucrose | Other: D-Fagomine<br>* 0 mg (control) blended with 50 grams of sucrose in 200 ml of water.<br>|
| Active Comparator: Product 1<br>200 ml water with 50g of sucrose and supplemented with 30 mg of D-Fagomine | Other: D-Fagomine<br>* 30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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