Revisions for Biomarkers of exposition_Uchuva Dorada | Registro Público Cubano de Ensayos Clínicos

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+sites/default/files/ReporteResultados-RPCEC-INGLÉS Diligenciado_0.pdf

Revision of 18 February 2021 - 3:32pm:

Biomarkers of exposition_Uchuva Dorada

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:

Uchuva_Bio

Scientific title:

Pilot study to identify candidates for biomarkers associated with Cape gooseberry consumption

Secondary indentifying numbers:

Agreement 1908

Issuing authority of the secondary identifying numbers:

CORPOICA

Source(s) of monetary or material support:

CORPOICA VIDARIUM

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:

Vanessa

Last name:

Corrales Agudelo

Medical Specialty :

Nutritionist. Master in Nutrition and Metabolism, Master in Basic Biomedical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal address:

Cl. 67 #52-20

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57-2856600 ext. 44566

Email address:

vcorrales@serviciosnutresa.com

vanecora@gmail.com

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:

Colombia

Clinical sites:

Not applicable

Research ethics committees:

Ethics Committee in Human Research, CES University, Medellin-Colombia. Date of approval September 20, 2017. Act 111

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

12/02/2018

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:

Not applicable. The study seeks to identify biomarkers associated with the acute and chronic consumption of cape gooseberry, and the impact of this consumption on the composition of the intestinal microbiota.

Health condition(s) code:

Healthy Volunteers

Biomarkers

Intervention(s):

Uchuva group (Experimental): Consume acutely 250 g of Cape gooseberry and during 20 days 150 /day using the scheme: Washout Period (8 days): Participants should avoid consuming Cape gooseberry, medicines of any kind, antioxidant supplements, vitamin A, β-carotene, natural products, supplements or dietary supplements or multivitamins. DAY 1 OF THE INTERVENTION (Basal): Controlled feeding designed by a nutritionist (everyone will eat the same during the day). Consume 250 ml of water sweetened with sugar (equivalent to the sugar contribution of 250 g of Cape gooseberry). Day 3 of the intervention (Acute): Controlled feeding as a day 1. They will consume 250 g of Cape gooseberry. CHRONIC INTERVENTION: Consume 150 g / day of Cape gooseberry from day 3 to 22. DAY 23 END OF THE INTERVENTION (chronic): Controlled feeding as day 1. Consume 250 ml of water sweetened with sugar (equivalent to the contribution of sugar of 250 g of Cape gooseberry).

Intervention code:

Physalis

Administration, Oral

Intervention keyword:

golden cape gooseberry

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):

Biomarkers of exposure to Cape gooseberry consumption in urine (Values expressed in nmol/ml determined by Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)). Measurement time: Day 1=Basal. 24h urine sample collected as follow: 0-6h, 6-12h and 12-24h; Day 3= Acute. 24h urine sample, after cape grossberry acute consumption, collected as follow: 0-6h, 6-12h and 12-24h; Day 23= Chronic. 24 h urine sample, after cape grossberry chronic consumption, collected as follow: 0-6h, 6-12h and 12-24h. Biomarkers of exposure to Cape gooseberry consumption will be determined in plasma (Values expressed in nmol/ml determined by Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)). Measurement time: Day 3= Acute. Plasma sample (10 ml of blood sample, fasting) and, 6 h after cape grossberry consumption. Day 23=Chronic. Plasma sample (10 ml of blood sample, fasting)

Key secondary outcomes:

Microbiota evaluation The abundance of OTUs (Operational Taxonomic Unites, defined at 97% similarity of DNA sequences of variable regions of the 16S rRNA gene; relative and absolute abundances will be calculated). Measurement time: Day 1= a feces sample, Day 23= a feces sample Post intervention= a feces sample, 30 days after the end of cape grossberry consumption.

Selection criterias

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

Gender:

Male

Minimum age:

20 years

Maximum age:

50 years

Inclusion criteria:

1. Male volunteers 2. With age ≥20 and ≤50 y 3. BMI between 18.8 Kg / mt2 and 24.9 Kg / mt2, 4. Consumers of cape gooseberries and citrus fruits 5. Non-smokers 6. Non- high performance athlete (subjects with a sedentary physical activity, mild or moderate, without exceeding 10 hours per week of training). 7. No history and/or diagnosis of chronic diseases (cardiovascular, hypertension, congestive heart failure, stroke, arrhythmias, dyslipidemia, diabetes mellitus, cancer, chronic renal failure, liver disorders, hypothyroidism, insomnia, duodenal ulcer, gastritis, disorders of malignancy absorption, Alzheimer's, Parkinson's or any other neurodegenerative disease that prevents an adequate collection of information, cancer, Crohn's disease, ulcerative colitis, short bowel syndrome or celiac disease, dysautonomies, sleep disorders and psychiatric disorders) 8. Not currently consuming medication (lipid-lowering drugs, antioxidant supplements, natural products, supplements or dietary supplements, multivitamins, antiepileptics, steroidal anti-inflammatories, hypnotic drugs) 9. Without antibiotic or antiparasitic use in the last three months. 10. Volunteers should have a work schedule between 7.00 a.m. and 6.00 p.m. from Monday to Friday and not having to leave the workplace during the time the study lasts.

Exclusion criteria:

1. Women.

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:

Other

Other purpose:

To identify biomarkers associated with the acute and chronic consumption of cape gooseberry

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

20

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:

Katalina

Last Name:

Munoz Durango

Specialty:

Pharmaceutical Chemist. Ph.D Chemical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal Address:

Cl. 67 #52-20 Laboratorio Vidarium. Torre B, piso 3

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+574 2856600 ext 44565

Email :

kmunos@gmail.com

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:

Vanessa

Last Name:

Corrales Agudelo

Specialty:

Nutritionist. Master in Nutrition and Metabolism, Master in Basic Biomedical Sciences

Affiliation:

Vidarium, Nutrition, Health and Wellness Research Center

Postal Address:

Cl. 67 #52-20

City:

Medellin

Country:

Colombia

Zip Code:

050010

Telephone:

+57 4 2856600 ext 44566

Email :

vcorrales@serviciosnutresa.com

vanecora@gmail.com

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

18

Study completion date:

10/10/2019

Date of available results:

03/03/2020

Date of first publication:

15/12/2021

Results Study

Section to complete the data related to the summarized results.

Participant flow:

See attachment

Baseline characteristics:

See attachment

Outcome measures:

See attachment

Adverse events:

See attachment

Summary study:

See attachment

Results file:

ReporteResultados-RPCEC-INGLÉS Diligenciado.pdf

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:

RPCEC00000268

Date of Registration in Primary Registry:

17/04/2018

Record Verification Date:

2021/02/18

Next update date:

2022/02/18

Link to the spanish version:

Click here

Registered Trials

Registration process

Biomarkers of exposition_Uchuva Dorada

About the RPCEC

Useful resources