Clinical trial NCT05840627: Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice
Official title: The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Men or women
* Adults (age ≥ 18 years)
* Filling informed consent

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Changes in gut microbiota characterization
timeFrame: 14 days
measure: Changes in gut microbiota diversity
timeFrame: 14 days
measure: Changes in the iAUC (pmol/L*min) for ghrelin
timeFrame: 14 days
measure: Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
timeFrame: 14 days
measure: Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
timeFrame: 14 days
Secondary outcomes:
measure: Changes in fasting glucose
timeFrame: 14 days
measure: Changes in fasting insulin
timeFrame: 14 days
measure: Changes in HOMA-IR
timeFrame: 14 days
measure: Changes in total cholesterol
timeFrame: 14 days
measure: Changes in LDL cholesterol
timeFrame: 14 days
measure: Changes in HDL cholesterol
timeFrame: 14 days
measure: Changes in triacylglycerols
timeFrame: 14 days
measure: Changes in high sensitivity PCR
timeFrame: 14 days
measure: Changes in expired breath H2
timeFrame: 14 days
measure: Changes in expired breath CH4
timeFrame: 14 days
measure: Changes in faecal butyrate
timeFrame: 14 days
measure: Changes in faecal acetate
timeFrame: 14 days
measure: Changes in faecal alkaline phosphatase (ALP)
timeFrame: 14 days
measure: Changes in faecal LPS
timeFrame: 14 days
measure: Changes in faecal calprotectin
timeFrame: 14 days
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Study officials:
References: