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

NCT05840627 | Completed

• 1 other identifier: cLabel+
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

• Changes in fasting glucose

  14 days

• Changes in fasting insulin

  14 days

• Changes in HOMA-IR

  14 days

• Changes in total cholesterol

  14 days

• Changes in LDL cholesterol

  14 days

Study Arms (1)

Fruit juice

EXPERIMENTAL

Other: Fruit juice

Interventions

Fruit juice OTHER

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

Fruit juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead

Study Sites (1)

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

Lisbon, Portugal

Location

MeSH Terms

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: May 3, 2023
• Study Start: February 28, 2023
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)