AzTrials
AzTrials

Metabolic SyndromeNCT05915117

Effects of Polyphenols of Pomegranate Fruit Peel Extract on Inflammation and Oxidative Stress in Metabolic Syndrome

A study testing Polyphenols of pomegranate fruit peel extract (PoPex) in people with Metabolic Syndrome, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the effects of polyphenols of pomegranate fruit peel extract compared to placebo on oxidative stress and inflammation in overweight and obese subjects with metabolic syndrome. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Polyphenols of pomegranate fruit peel extract (PoPex)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteBosnia and Herzegovina
Study dates
1 Apr 2023to 20 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Informed consent signed Adults of 20 to 60 years BMI ≥ 25.00 kg/m2
  • Met criteria for metabolic syndrome such as visceral obesity( for men ≥ 94 cm and ≥ 80 cm for women) and at least two risk factors:
  • TG ≥ 1,7 mmol/l, or present therapy for dyslipidemia
  • HDL <1,03 mmol/l men, <1,29 mmol/l women
  • Arterial blood pressure ≥130/85 mmHg
  • Glycemia ≥ 5.6 mmol/l and < 6.9 mmol/l

Who cannot join

  • Subjects with malignant and other acute and chronic infectious and non-infectious disease requiring active pharmacotherapy.
  • Subjects with with insulin dependent diabetes mellitus or subjects with insulin independent diabetes mellitus taking oral hypoglycemic therapy Subjects with uncontrolled chronic cardiovascular, endocrine, autoimmune, psychiatric, and autoimmune diseases or other condition based on the investigator judgement.
  • Non adherent subject Systematic use of corticosteroids Pregnant or lactating women Chronic use of supplements (omega 3 unsaturated acids, silymarin, mineral-vitamin supplements) Participation in any other interventional study

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site

  • Public Health Institution Dom zdravlja Banja Luka

    Banja Luka, Republika Srpska, 78000

Other trials in Bosnia and Herzegovina

About this study

Official title: Randomized, Double-blind, Placebo-controlled Study of Efficacy Polyphenols of Pomegranate Fruit Peel Extract on Inflammatory Parameters and Oxidative Stress in Overweight and Obese Subjects With Metabolic Syndrome

The purpose of this study is to evaluate the effects of polyphenols of pomegranate fruit peel extract compared to placebo on oxidative stress and inflammation in overweight and obese subjects with metabolic syndrome.

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled evaluation of the efficacy of polyphenols of pomegranate fruit peel extract on oxidative stress and inflammation in overweight and obese subjects with metabolic syndrome.

Study site: a single study center (Primary Health Care Institution in Banja Luka, as recruiter center) as recruitment center including Center for Biomedical Research, Faculty of Medicine University of Banja Luka, as local laboratory and coordinator.

Sample size: 60 subjects, randomized in a 1:1 allocation ratio.

Primary objectives are to investigate an effect of polyphenols pomegranate fruit peel extract on: Anthropometric parameters such as body mass index, and arterial blood pressure, glycemia, lipoprotein profile, homeostatic model assessment for insulin resistance (HOMAIR), homocysteine, vitamin B complex: folic acid, vitamin B6, vitamin B9 and vitamin B12.

  1. To investigate the effects polyphenols from pomegranate fruit peel extract has on impact on lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutathione (GSH), catalase (CAT) and superoxide dismutase (SOD).
  2. Proinflammatory markers interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high sensitive CRP (hsCRP), leptin, resistin ,vaspin, chemerin, lipokalin-2 and katepsin .
  3. Anti-infammatory markers IL-5, IL-10, IL-12 ,adiponectin and omentin.

Treatments arms:

Polyphenols of pomegranate fruit peel extract (PoPeEx) (500 mg/day) Placebo

Treatment duration :

8 weeks

Assessment - clinical and laboratory sampling:

Informed consent and Screening - 7 days prior to randomization

Study visits (V):

V1 - Randomization and Enrollment (Baseline) V2 - 4 weeks after Baseline V3 - 8 weeks after Baseline.

No interim analysis is planned. The analysis will be performed at the end of the study after data review and freezing of the database according to the intent to treat principle.

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Being tested
Polyphenols of pomegranate fruit peel extract (PoPex), Placebo
Keywords
Metabolic syndrome, Inflamation, Oxidative stress, Obesity, Polyphenols of Pomegranate Fruit Peel Extract
Medical subject headings
Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyphenols of pomegranate fruit peel extract (PoPex)Dietary supplement

    Also called Granat

    PoPex in form of capsule will be orally administered in total daily dose of 500/mg in subjects with metabolic syndrome and obesity over 8 weeks.

  • PlaceboDrug

    Placebo in form of capsule will be orally administered in subjects with metabolic syndrome and obesity over 8 weeks.

Study groups in NCT05915117
Study groupRoleWhat they receive
Polyphenols of pomegranate fruit peel extract (PoPex)ExperimentalAll subjects will treated only with PoPex in total daily dosis of 500 mg/orally over 8 weeks.
Receives: Dietary Supplement: Polyphenols of pomegranate fruit peel extract (PoPex)
PlaceboPlacebo comparatorAll subjects will treated only with PoPex placebo capsules/orally over 8 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in oxidative stress biomarkers levels: lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutation (GSH), catalasis(CAT) and superoxid dismutasis(SOD).

    ELISA assey

    Measured: From Baseline and after 8 weeks

  2. Change in proinflammatori parametars:interleukin-6 (IL-6), tumor necrosis factor-α (TNF- α), high sensitive CRP (hsCRP), leptin, resistin ,vaspin, chemerin ,lipokalin -2 and katepsin

    ELISA assey

    Measured: From Baseline and after 8 weeks

  3. Change in antiinflammatori parametars:interleukin -5 (IL-5) ,interleukin-10(IL-10), interleukin-12 (IL-12) ,adiponectin and omentin

    ELISA assey

    Measured: From Baseline and after 8 weeks

Secondary outcomes (8)

  1. Change in inflammation marker level : high sensitivity CRP Turbid mertic test

    Turbid metric test

    Measured: From Baseline and after 8 weeks

  2. Change in total choleterol (TC), low -density lipoprotein ( LDL), high-density lipoprotein (HDL) and trglicerides Turbid mertic test

    Clinical biochemistry (colorimetric) test and results will be expressed in mmol/l

    Measured: From Baseline,after 4 and 8 weeks

  3. Change in serum levels homocystein

    Detection by fluoroscence polarization immunoassay

    Measured: From Baseline,after 4 and 8 weeks

  4. Change in serum levels of vitamin B6-piridoxin ,vitamin B9-folic acid ,vitamin B12-cianocobalamin

    Microparticle enzyme immunoassey

    Measured: From Baseline, after 4 and 8 weeks

  5. Change in serum levels of glycemia, insulinemia

    glycemia-hexokinase method,insulinemia-ultrasensitivity test,immunoenzyme test:"sandwich"

    Measured: From Baseline,after 4 and after 8 weeks

  6. Change in serum levels of liver function tests

    IFCC,reference method with pyridoxyl phosphate

    Measured: From Baseline,after 4 and after 8 weeks

  7. Change in body weight

    weight ( kg)

    Measured: From Baseline and after 8 weeks

  8. Change in systolic and diastolic blood presure

    mm/HG

    Measured: From Baseline and after 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start1 Apr 2023
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915117
Sponsor's protocol ID
PoPexMetSy
Status last verified
Apr 2023
First submitted
13 Jun 2023
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grabez M, Skrbic R, Stojiljkovic MP, Vucic V, Rudic Grujic V, Jakovljevic V, Djuric DM, Surucic R, Savikin K, Bigovic D, Vasiljevic N. A prospective, randomized, double-blind, placebo-controlled trial of polyphenols on the outcomes of inflammatory factors and oxidative stress in patients with type 2 diabetes mellitus. Rev Cardiovasc Med. 2022 Feb 11;23(2):57. doi: 10.31083/j.rcm2302057.

    PubMed 35229548

Questions about this trial

What is this clinical trial studying?

A study testing Polyphenols of pomegranate fruit peel extract (PoPex) in people with Metabolic Syndrome, run by University of Banja Luka at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in oxidative stress biomarkers levels: lipid peroxidation index, nitric oxide metabolites, hydrogen peroxide (H2O2), superoxide anion radical (O2-), and glutation (GSH), catalasis(CAT) and superoxid dismutasis(SOD). (time frame: From Baseline and after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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