Study [AGER-MELO] study / subjects / design / samples / assays

Basic properties of your study This page shows the basic information about your study, as well as information on the authorizations.

Publications

Contacts

  • Bouwman, Jildau
    Data Submission

Authorization

Public Design
Yes
Readers
Writers
josep.rubert
Josep.Rubert
Study title
Apple fruit quality in the post-genomic era from breeding new genotypes to post-harvest: nutrition and health
Template
Intervention/Observation study
title
Apple fruit quality in the post-genomic era from breeding new genotypes to post-harvest: nutrition and health
description
The aim of the study was to effectively identify the metabolic products of various classes of apple polyphenols upon ingestion by healthy subjects using an untargeted metabolomic approach and to follow in the nutrikinetics of these metabolites in plasma and urine over respectively a 5 h and 24 h period. A second aim was to evaluate whether an higher concentration of polyphenols in the apple matrix, i.e. the consumption from the same volunteers either of the cloudy apple juice (CAJ) or the polyphenol enriched apple juice (PAJ) would lead to a corresponding increased metabolic output. An additional aim was to assess whether particular profiles of apple derived plasma/urine metabolites could be related to individual members of the gut microbiota. Metabolights Code: MTBLS473
code
AGER-MELO
startDate
2011-01-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Fulvio Mattivi, Cristina Scaccini
Objectives
The aim of the study was to effectively identify the metabolic products of various classes of apple polyphenols upon ingestion by healthy subjects using an untargeted metabolomic approach and to follow in the nutrikinetics of these metabolites in plasma and urine over respectively a 5 h and 24 h period. A second aim was to evaluate whether an higher concentration of polyphenols in the apple matrix, i.e. the consumption from the same volunteers either of the cloudy apple juice (CAJ) or the polyphenol enriched apple juice (PAJ) would lead to a corresponding increased metabolic output. An additional aim was to assess whether particular profiles of apple derived plasma/urine metabolites could be related to individual members of the gut microbiota
Exclusion criteria
dependence alcohol consumption; known allergies/ inntolerance to apples; age 18-40; acute or chronic metabolic disorders; smoking habits; use of pharmacetuclas or drugs; use of dietary vitamin supplements, MBI range 18.5 e 25 kg/m2
Institute
Fondazione Edmund Mach, Department of Food Quality and Nutrition and Area Scientifica e Tecnologica Scienze della Nutrizione Istituto Nazionale di Ricerca per
Funding body
This research funded by the AGER (Agribusiness and research) with grant no. 2010-2119 and Fondazione Cariplo
Was the study approved by an ethics committee?
Yes
Ethical approval number
approved by the Ethical Committee of the National Research Institute for Food and Nutrition (0003288/01.11).
Did the individuals providing data sign informed consent?
Yes
Study design
Case-control
Description of "Start groups"
Time-series
Control group
Yes
Type of controls
Cloudy apple juice
Randomisation
Yes
Blinding (yes/no)
Yes
Blinding method
Envelopes without safeguards (e.g. unsealed or transparent or un-numbered);
Study terminated?
Yes
Compliance assessed?
Yes
Compliance assessment (for each treatment)
phloretin levels in plasma and urine
Factorial design?
Yes
Number of factors (for factorial designs only)
3
Total number of arms (Give number of distinct treatments in study)
2
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
Twelve, non-smoking, healthy volunteers (8 males and 4 females), aged 21 to 42 years, with a BMI between 18.5 and 25 kg/m2 (normal weight), participated in the randomized crossover study. Volunteers were instructed to refrain from consuming phenol-rich foods and beverages (wine, coffee, tea, fruits and vegetables), dietary supplements and medications in the three days prior to the experiments. To ensure adherence to the dietary guidelines, we asked the subjects to keep a 3-day dietary record prior the study participation. Compliance with the dietary guidelines was good. The subjects reported to the laboratory on 2 separate occasions, 2 weeks apart, after fasting overnight (10-12 h). A venous blood sample was taken at time 0. Immediately after the first blood collection, participants were provided with a glass of CAJ (250 ml) (CAJ Treatment) or a glass of PAJ (250 ml) (PAJ Treatment).
Number of volunteers enrolled N(M:xx, F: xx)
12
Number of subjects (Male; Female)
12
Start of recruitment (Start year or date)
2013-06-01 00:00:00.0
End of recruitment (End year or date)
2017-06-16 00:00:00.0
Follow-up
No

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