Acute Satiety and Metabolic Response of Daily Consumption of a Fruit Juice

NCT ID: NCT05840627

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2023-04-06

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fruit juice

Group Type: EXPERIMENTAL

Fruit juice

Intervention Type: OTHER

Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.

Interventions

Fruit juice

Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

cLabel+

Identifier Type: -

Identifier Source: org_study_id