Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice
- Conditions
- Healthy
- Interventions
- Other: Fruit juice
- Registration Number
- NCT05840627
- Lead Sponsor
- Universidade Nova de Lisboa
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Men or women
- Adults (age ≥ 18 years)
- Filling informed consent
- Obesity (body mass index ≥ 30.0 kg/m2).
- Daily consumption of fruit juices in the month prior to the start of the study.
- Individuals with diagnosed food allergies or intolerances to the components being tested.
- Use of pro/prebiotics or fibre as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
- Use of laxatives 6 weeks before recruitment.
- Recent weight loss or weight gain of more than 10% in the last 3 months.
- Adherence to restrictive weight loss diets or specific dietary pattern (e.g., palaeolithic diet, Atkins, flexitarian, ketogenic, vegan).
- Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease, or diabetes mellitus.
- Having taken antibiotics within the 12 weeks prior to beginning the study.
- Excessive consumption of alcoholic beverages (>14 and >8 units/week for men and women, respectively).
- Pregnant or breastfeeding.
- Participation in another clinical trial within the past 3 months that the Principal Investigator believes may compromise the results of the trial (e.g., clinical trial with an effect on the composition and diversity of the gut microbiota).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fruit juice Fruit juice -
- Primary Outcome Measures
Name Time Method Changes in the iAUC (pmol/L*min) for ghrelin 14 days 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.
Changes in gut microbiota diversity 14 days Difference in gut microbiota Shannon index, from baseline to the end of intervention.
Changes in gut microbiota characterization 14 days Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.
Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1) 14 days 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.
Changes in the iAUC (pmol/L*min) for peptide YY (PYY) 14 days 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.
- Secondary Outcome Measures
Name Time Method Changes in fasting glucose 14 days Changes in fasting glucose, measured in mg/dL, from baseline to the end of intervention.
Changes in fasting insulin 14 days Changes in fasting insulin, measured in mg/dL, from baseline to the end of intervention.
Changes in HOMA-IR 14 days Changes in HOMA-IR from baseline to the end of intervention.
Changes in total cholesterol 14 days Changes in total cholesterol, measured in mg/dL, from baseline to the end of intervention.
Changes in LDL cholesterol 14 days Changes in LDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Changes in HDL cholesterol 14 days Changes in HDL cholesterol, measured in mg/dL, from baseline to the end of intervention.
Changes in expired breath H2 14 days Changes in expired breath H2, measured in ppm, from baseline to the end of intervention.
Changes in faecal calprotectin 14 days Changes in faecal calprotectin, measured in µg/g faeces, from baseline to the end of intervention.
Changes in faecal acetate 14 days Changes in faecal acetate, measured in M, from baseline to the end of intervention.
Changes in faecal LPS 14 days Changes in faecal LPS, measured in EU/mL, from baseline to the end of intervention.
Changes in triacylglycerols 14 days Changes in triacylglycerols, measured in mg/dL, from baseline to the end of intervention.
Changes in high sensitivity PCR 14 days Changes in high sensitivity PCR, measured in mg/dL, from baseline to the end of intervention.
Changes in expired breath CH4 14 days Changes in expired breath CH4, measured in ppm, from baseline to the end of intervention.
Changes in faecal butyrate 14 days Changes in faecal butyrate, measured in M, from baseline to the end of intervention.
Changes in faecal alkaline phosphatase (ALP) 14 days Changes in faecal ALP, measured in mg/g faeces, from baseline to the end of intervention.
Trial Locations
- Locations (1)
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
🇵🇹Lisboa, Portugal