Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

Universidade Federal do Rio de Janeiro

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Fish protein hydrolysates; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03318913

53392216.0.0000.5699

Details and patient eligibility

About

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease of abnormal carbohydrate metabolism which is related with high morbidity and mortality rates caused by its complications. One of the major diabetes-related arterial phenotypes thought to be responsible for development of cardiovascular disease is endothelial dysfunction. Nitric oxide (NO) is a potent molecule derived of endothelium, which plays key role in control of vascular tone. In T2DM present endothelial dysfunction due to reduced NO bioavailability. Fish protein hydrolysates (FPH) have been showed to present antioxidant peptides (and high value of ACE inhibition activity. Therefore, the present study aimed to examine whether single dose of FPH ingestion would reversal macro- and microvascular endothelial dysfunction in T2DM.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus

Exclusion criteria

• History of symptomatic coronary artery disease;
• Stroke or other known atherosclerotic disease;
• Cancer;
• HIV positive;
• Alcohol or drug abuse within the past 6 months previous the visit 1;
• use any antioxidant supplementation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

22 participants in 3 patient groups, including a placebo group

Health control

No Intervention group

Description:

Health young subjects free of diabetes mellitus and nutritional intervention

DM Placebo

Placebo Comparator group

Description:

Sucralose

Treatment:

Other: Placebo

DM FHP

Active Comparator group

Description:

Fish protein hydrolysates

Treatment:

Other: Fish protein hydrolysates