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

The Effect of Daily Consumption of a Fruit Juice on Acute Satiety Response and Gut Microbiota Changes in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Fruit juice

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fruit juice	Other: Fruit juice; Daily consumption of 200 mL of fruit juice at lunch for 14 consecutive days, provided by the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbiota characterization	Differences in gut microbiota taxonomic characterization from baseline to the end of the intervention.	14 days
Changes in gut microbiota diversity	Difference in gut microbiota Shannon index, from baseline to the end of intervention.	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.	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.	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting glucose	Changes in fasting glucose, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in fasting insulin	Changes in fasting insulin, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in HOMA-IR	Changes in HOMA-IR from baseline to the end of intervention.	14 days
Changes in total cholesterol	Changes in total cholesterol, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in LDL cholesterol	Changes in LDL cholesterol, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in HDL cholesterol	Changes in HDL cholesterol, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in triacylglycerols	Changes in triacylglycerols, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in high sensitivity PCR	Changes in high sensitivity PCR, measured in mg/dL, from baseline to the end of intervention.	14 days
Changes in expired breath H2	Changes in expired breath H2, measured in ppm, from baseline to the end of intervention.	14 days
Changes in expired breath CH4	Changes in expired breath CH4, measured in ppm, from baseline to the end of intervention.	14 days
Changes in faecal butyrate	Changes in faecal butyrate, measured in M, from baseline to the end of intervention.	14 days
Changes in faecal acetate	Changes in faecal acetate, measured in M, from baseline to the end of intervention.	14 days
Changes in faecal alkaline phosphatase (ALP)	Changes in faecal ALP, measured in mg/g faeces, from baseline to the end of intervention.	14 days
Changes in faecal LPS	Changes in faecal LPS, measured in EU/mL, from baseline to the end of intervention.	14 days
Changes in faecal calprotectin	Changes in faecal calprotectin, measured in µg/g faeces, from baseline to the end of intervention.	14 days

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: cLabel+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No