Antioxidant efcts of Abexol in middle-aged and older subjects

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

A/P-01

Scientific title:

Abexol effect on indicators of oxidative stress and quality of life in middle-aged and older subjects

Acronym of Scientific Title:

Abe/P-01

Secondary indentifying numbers:

Abe/Pla-01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research (CNIC)

Source(s) of monetary or material support:

National Centre for Scientific Research, BioCubafarma Central count

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Luis

Midle name:

Ernesto

Last name:

Lopez Gonzalez

Medical Specialty :

Second Degree specialist of Internal Medicine

Affiliation:

Surgical Medical Research Centre (CIMEQ)

Postal address:

216 st and 11B, Siboney, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-78581000

Email address:

luisernesto.lopez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

17/07/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Oxidative strees in middle-aged and older subject

Health condition(s) code:

Oxidative Stress

Aging

Intervention(s):

Group 1 Placebo (Control): Placebo, two tablets by oral route, one a day, for 12 weeks Group 2 Abexol (Experimental): Abexol (50 mg), two tablets by oral route, one a day, for 12 weeks

Intervention code:

Dietary Supplements

Tablets

Administration, Oral

Intervention keyword:

Abexol

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Malondiialdehyde (MDA) (nmmol/MDA/mL). Measurement time: At baseline and 12 weeks (Significant decrease of values at the end of treatment respect baseline values and values of the placebo group) 2. Total Hydroperoxides (nmol/mg protein). Measurement time: At baseline and 12 weeks (Significant decrease of values at the end of treatment respect baseline values and values of the placebo group)

Key secondary outcomes:

Total antioxidant status (mL whole blood). Measurement time: At baseline ans 12 weeks (Singnifican increase of values at the end of treatment respect baseline values and values of the placebo group)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

40 years

Maximum age:

75 years

Inclusion criteria:

Subjects who provided written informed consent for participating in the trial

Exclusion criteria:

Patients with: 1) Diagnosed thyroid 2) Hepatic and/or renal diseases active 3) Diagnosed cancer 4) Uncontrolled diabetes (fasting glucose a head 7) 5) Arterial hypertension (diastolic pressure a head 100 mmHg) 6) Values of blood indicators: ALT or AST a head 55 UI, creatinine a head 130 umol/L 7) Has suffered myocadial infarction, unstable angina, stroke, ATI, major surgery, within six months prior the study 8) Consuming antioxidant supplements or vitamins within the last 4 weeks prior the trial

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

3

Target sample size:

50

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Dr. Pharmaceutical Science

Affiliation:

Unit of Clinical Trials, National Centre for Scientific Research (CNIC)

Postal Address:

Avenue 25 and 158 st, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

Dr. Pharmaceutical Science

Affiliation:

Unit of Clinical Trials, National Centre for Scientific Research (CNIC)

Postal Address:

Avenue 25 and 158 st, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Surgical Medical Research Centre (CIMEQ)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/06/2007

Postal address of Ethic Committee :

216 st and 11B, Siboney, Playa, ZC: 11300. Havana, Cuba

Telephone:

+53-72718424

Correo electrónico:

bcimeq@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

50

Study completion date:

12/10/2007

Date of available results:

12/01/2008

Date of first publication:

01/04/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000401

Date of Registration in Primary Registry:

20/03/2022

Record Verification Date:

2022/03/31

Next update date:

2023/03/31

Link to the spanish version:

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Antioxidant efcts of Abexol in middle-aged and older subjects

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