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Biomarkers of exposition_Uchuva Dorada
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17 Abril 2018 - 5:04pm
por Gladys
18 Febrero 2021 - 3:32pm
por kmunoz
Cambios a
Data sharing plan
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Not entered
Cambios a
Date of first enrollment
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2018-02-12
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2018-02-12
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Cambios a
Final enrolment number
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18
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Study completion date
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2019-10-10T00:00:00
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Date of available results
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2020-03-03T00:00:00
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Date of first publication
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2021-12-15T00:00:00
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Record Verification Date
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2018
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04
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17
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2021
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02
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18
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Next update date
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2019
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04
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17
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2022
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02
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18
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Source(s) of monetary or material support
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CORPOICA
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CORPOICA VIDARIUM
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VIDARIUM
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Cambios a
Participant flow
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See attachment
Cambios a
Baseline characteristics
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See attachment
Cambios a
Outcome measures
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See attachment
Cambios a
Adverse events
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See attachment
Cambios a
Summary study
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See attachment
Cambios a
Results file
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sites/default/files/ReporteResultados-RPCEC-INGLÉS Diligenciado_0.pdf
Revisión de 18 Febrero 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
Primary sponsor:
CORPOICA
Secondary sponsor:
Not applicable
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
País:
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
País:
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
País:
Colombia
Zip Code:
050010
Telephone:
+57 4 2856600 ext 44566
Email :
vcorrales@serviciosnutresa.com
vanecora@gmail.com
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Not entered
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
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