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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Placebo; Other: Fish protein hydrolysates

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro
    • Macaé, Rio De Janeiro, Brazil, 27979000
      • Federal University of Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Health control; Health young subjects free of diabetes mellitus and nutritional intervention
Placebo Comparator: DM Placebo; Sucralose	Other: Placebo; 5g of the sucralose administered as white plastic capsules
Active Comparator: DM FHP; Fish protein hydrolysates	Other: Fish protein hydrolysates; 5g of the FPH dissolving in 100 mL of water

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): March 28, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Vascular function; Fish protein hydrolysates
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 53392216.0.0000.5699

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No