An interventional study of Fruit juice in Healthy, sponsored by Universidade Nova de Lisboa. Completed at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Universidade Nova de Lisboa · Not applicable, Interventional, and Other
The "cLabel+ Innovative natural, nutritious and consumer-oriented clean label food" is a research and technological development project centered on responding to the challenges facing the food industry. It is focused on the concept of "clean label", which emerges as one of the major current trends in the sector, given the growing number of consumers who are increasingly aware and eager for information, who are looking for alternative, more transparent and natural food products.
Thus, one of the aims of the cLabel+ project is to research the macronutrients and phenolic compounds present in food matrices and achieve a clean label positioning for the final products developed. This single group assignment clinical trial aims to evaluate the effect of daily consumption of a fruit juice, developed as part of the collaborative project cLabel+, on gut microbiota composition and diversity in healthy adults. It is also intended to study the acute metabolic effect, namely in terms of appetite control, and lipid and glucose metabolism.
Universidade Nova de Lisboa is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Fruit juice
Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.
Changes in gut microbiota characterization
Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.
Time frame: 14 days
Changes in gut microbiota diversity
Difference in gut microbiota Shannon index, from baseline to the end of intervention.
Time frame: 14 days
Changes in the iAUC (pmol/L*min) for ghrelin
Ghrelin will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for ghrelin will be calculated based on the concentration curve following consumption of the fruit juice.
Time frame: 14 days
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
GLP-1 will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for GLP-1 will be calculated based on the concentration curve following consumption of the fruit juice.
Time frame: 14 days
Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
PYY will be measured in fasting and every 30 minutes up to 3 hours. The iAUC (pmol/L\*min) for PYY will be calculated based on the concentration curve following consumption of the fruit juice.
Time frame: 14 days
Changes in fasting glucose
Changes in fasting glucose, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in fasting insulin
Changes in fasting insulin, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in HOMA-IR
Changes in HOMA-IR from baseline to the end of intervention.
Time frame: 14 days
Changes in total cholesterol
Changes in total cholesterol, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in LDL cholesterol
Changes in LDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in HDL cholesterol
Changes in HDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in triacylglycerols
Changes in triacylglycerols, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in high sensitivity PCR
Changes in high sensitivity PCR, measured in mg/dL, from baseline to the end of intervention.
Time frame: 14 days
Changes in expired breath H2
Changes in expired breath H2, measured in ppm, from baseline to the end of intervention.
Time frame: 14 days
Changes in expired breath CH4
Changes in expired breath CH4, measured in ppm, from baseline to the end of intervention.
Time frame: 14 days
Changes in faecal butyrate
Changes in faecal butyrate, measured in M, from baseline to the end of intervention.
Time frame: 14 days
Changes in faecal acetate
Changes in faecal acetate, measured in M, from baseline to the end of intervention.
Time frame: 14 days
Changes in faecal alkaline phosphatase (ALP)
Changes in faecal ALP, measured in mg/g faeces, from baseline to the end of intervention.
Time frame: 14 days
Changes in faecal LPS
Changes in faecal LPS, measured in EU/mL, from baseline to the end of intervention.
Time frame: 14 days
Changes in faecal calprotectin
Changes in faecal calprotectin, measured in µg/g faeces, from baseline to the end of intervention.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Universidade Nova de Lisboa