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

Bioglane

Status: Completed

Conditions: Glycaemic Response; Insulinemic Response

Treatments: Other: D-Fagomine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01528631

1AP029010911

Details and patient eligibility

About

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

Full description

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

Enrollment: 12 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Control Product

Placebo Comparator group

Description:

200 ml water with 50g of sucrose

Treatment:

Other: D-Fagomine

Other: D-Fagomine

Product 1

Active Comparator group

Description:

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

Treatment:

Other: D-Fagomine

Other: D-Fagomine