Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03318913

Enrollment

Registered

2017-10-24

Start date

2017-10-23

Completion date

2018-03-28

Last updated

2019-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Vascular function, Type 2 diabetes mellitus, Fish protein hydrolysates

Brief summary

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.

Interventions

OTHERPlacebo

5g of the sucralose administered as white plastic capsules

OTHERFish protein hydrolysates

5g of the FPH dissolving in 100 mL of water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Double blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Flow-mediated dilation	60 min after nutritional intervention	macrovascular endothelial function
Near infrared spectroscopy	70 min after nutritional intervention	microvascular endothelial function
High performance liquid chromatography	75 min after nutritional intervention	serum amino acids

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026