Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

• Sponsor: Universidade Federal do Rio de Janeiro (Other)
• Overall Status: Completed
• CT.gov ID: NCT03318913
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Placebo; Other: Fish protein hydrolysates	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double blind
• Primary Purpose: Treatment
• Official Title: Effect of Acute Fish Protein Hydrolysates Ingestion on Vascular Function of the Type 2 Diabetes Subjects
• Actual Study Start Date: Oct 23, 2017
• Actual Primary Completion Date: Feb 15, 2018
• Actual Study Completion Date: Mar 28, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Flow-mediated dilation [60 min after nutritional intervention]

   macrovascular endothelial function

2. Near infrared spectroscopy [70 min after nutritional intervention]

   microvascular endothelial function

3. High performance liquid chromatography [75 min after nutritional intervention]

   serum amino acids

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Rio de Janeiro	Macaé	Rio De Janeiro	Brazil	27979000

Sponsors and Collaborators

• Universidade Federal do Rio de Janeiro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thiago Alvares, D.sc, Universidade Federal do Rio de Janeiro
• ClinicalTrials.gov Identifier: NCT03318913
• Other Study ID Numbers: 53392216.0.0000.5699
• First Posted: Oct 24, 2017
• Last Update Posted: Dec 13, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Thiago Alvares, D.sc, Universidade Federal do Rio de Janeiro: Vascular function; Type 2 diabetes mellitus; Fish protein hydrolysates
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 13, 2019