Biomarkers of exposition_Uchuva Dorada

Not Applicable

• Conditions: ot 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.; Healthy Volunteers; Biomarkers

• Registration Number: RPCEC00000268
• Lead Sponsor: CORPOICA

Brief Summary

See attachment

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Study Completion: 2020-03-03
• Results First Posted: 2021-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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)

Secondary Outcome Measures

Name	Time	Method
Microbiota evaluation <br>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.