Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters

NCT05810922 | Completed

• 1 other identifier: F4F- Forest for Future
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The tree that produces the arbutus berry, the strawberry tree, scientific name Arbutus unedo L., belongs to the family of Ericaceae. It exists in almost all of Southern Europe in arid and siliceous lands, in woods and forests and is very common in Portugal. Known for its use in the production of liqueurs and brandy, the arbutus berry is a fruit that can be consumed in nature or incorporated in the preparation of other foods. Arbutus berry has been attributed some properties beneficial to health given its low caloric value and its high content of vitamin C and flavonoids, which is why it is considered a good source of antioxidants. Arbutus has a high carbohydrate content (70-80% dry weight) with a relevant fiber fraction (10-30%), constituting an interesting source of vegetable protein (1-9%) and lipids (2-3%). Given this interesting nutritional composition, the hypothesis is that a daily consumption of this fruit can have an impact in health outcomes such as microbiota modulation and an improvement of metabolic parameters.

Conditions

Diet Habit

Keywords

adipokines; arbutus berry; gut microbiota; inflammatory cytokines; short chain fatty acid; strawberry tree

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiota characterization

  Difference in gut microbiota taxonomic characterization, from baseline to the end of intervention

  14 days

• Changes in gut microbiota diversity

  Difference in gut microbiota Shannon index, from baseline to the end of intervention

  14 days

Secondary Outcomes (14)

• Changes in fasting glucose

  14 days

• Changes in HOMA-IR

  14 days

• Changes in HDL cholesterol

  14 days

• Changes in total cholesterol

  14 days

• Changes in LDL cholesterol

  14 days

Study Arms (2)

50 g arbutus berry

EXPERIMENTAL

consumption of 50 g arbutus berry/day for 14 days

Other: arbutus berry

200 g arbutus berry

EXPERIMENTAL

consumption of 200 g arbutus berry/day for 14 days

Other: arbutus berry

Interventions

arbutus berry OTHER

consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days

200 g arbutus berry; 50 g arbutus berry

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian.
• Age between 18 and 50 years.
• Filling informed consent.
• Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.

You may not qualify if:

• Arbutus berry sensibility.
• Arbutus berry daily consumption in the month before the study begin.
• Having taken antibiotics within the 6 months prior to beginning the study.
• Use of pro/prebiotics or fiber as a dietary supplement or any food/molecule that modifies intestinal transit time 6 weeks before recruitment.
• Use of laxative 6 weeks before recruitment.
• Specific nutritional therapy (e.g. high protein).
• Excessive alcohol consumption.
• Smoking.
• Diagnosis of gastrointestinal pathology, hormonal or thyroid pathology, autoimmune diseases, chronic use of corticosteroids, psychiatric disease or Diabetes Mellitus.
• Use of proton pump inhibitors, antidiabetic drugs, insulin, or statins.
• Pregnant or breastfeeding.
• Participation in another clinical trial within the last 3 months.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA): collaborator

Study Sites (1)

Nova Medical School Universidade Nova de Lisboa

Lisbon, 1169-056, Portugal

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Ana Faria, PhD

  Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 13, 2023
• Study Start: November 8, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)