CClinicalTrials.gg
Sign In
CompletedNCT03318913Updated Dec 13, 2019

Vascular Function, Fish Protein Hydrolysates and Type 2 Diabetes Mellitus

An interventional study of Placebo and Fish protein hydrolysates in Diabetes Mellitus, Type 2, sponsored by Universidade Federal do Rio de Janeiro. Completed at 1 site in Brazil. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-13.

Sponsored by Universidade Federal do Rio de Janeiro · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Vascular function
  • Type 2 diabetes mellitus
  • Fish protein hydrolysates
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Type 2 diabetes mellitus

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • No intervention
    Health control

    Health young subjects free of diabetes mellitus and nutritional intervention

  • Placebo comparator
    DM Placebo

    Sucralose

    Other: Placebo

  • Active comparator
    DM FHP

    Fish protein hydrolysates

    Other: Fish protein hydrolysates

Interventions

  • OtherPlacebo

    5g of the sucralose administered as white plastic capsules

  • OtherFish protein hydrolysates

    5g of the FPH dissolving in 100 mL of water

05

What researchers measure

Primary outcomes

  1. Flow-mediated dilation

    macrovascular endothelial function

    Time frame: 60 min after nutritional intervention

  2. Near infrared spectroscopy

    microvascular endothelial function

    Time frame: 70 min after nutritional intervention

  3. High performance liquid chromatography

    serum amino acids

    Time frame: 75 min after nutritional intervention

06

Study locations

1 site
  • Federal University of Rio de Janeiro
    Macaé, Rio De Janeiro 27979000, Brazil
07

Registry details

Key details

Study ID
NCT03318913
Lead sponsor
Universidade Federal do Rio de Janeiro
Responsible party
Thiago Alvares (D.sc, Universidade Federal do Rio de Janeiro) — Principal investigator
First posted
Oct 24, 2017
Start date
Oct 23, 2017
Primary completion
Feb 15, 2018
Completion
Mar 28, 2018
Last update
Dec 13, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Universidade Federal do Rio de Janeiro

Start the discussion