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Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

NCT ID: NCT03318913

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Vascular function Type 2 diabetes mellitus Fish protein hydrolysates

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double blind

Study Groups

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Health control

Health young subjects free of diabetes mellitus and nutritional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

DM Placebo

Sucralose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

5g of the sucralose administered as white plastic capsules

DM FHP

Fish protein hydrolysates

Group Type ACTIVE_COMPARATOR

Fish protein hydrolysates

Intervention Type OTHER

5g of the FPH dissolving in 100 mL of water

Interventions

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Placebo

5g of the sucralose administered as white plastic capsules

Intervention Type OTHER

Fish protein hydrolysates

5g of the FPH dissolving in 100 mL of water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

D.sc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Rio de Janeiro

Macaé, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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53392216.0.0000.5699

Identifier Type: -

Identifier Source: org_study_id