Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters (F4F)

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.

Study Overview

• Status: Completed
• Conditions: Diet Habit
• Intervention / Treatment: Other: arbutus berry

Detailed Description

The main objective of this clinical trial is to evaluate the effect of including a daily consumption of arbutus berry on the composition and diversity of the intestinal microbiota. It is also intended to evaluate metabolic parameters to determine the impact of this intervention.

Participants will consume 50g or 200g of arbutus berry daily for 4 weeks. This study aims to provide scientific evidence regarding the impact of arbutus berry consumption on intestinal microbiota and general health improvements.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1169-056
    • Nova Medical School Universidade Nova de Lisboa

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 g arbutus berry; consumption of 50 g arbutus berry/day for 14 days	Other: arbutus berry; consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days
Experimental: 200 g arbutus berry; consumption of 200 g arbutus berry/day for 14 days	Other: arbutus berry; consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting glucose	Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention	14 days
Changes in HOMA-IR	Changes in HOMA-IR from baseline to end of intervention	14 days
Changes in total cholesterol	Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention	14 days
Changes in LDL cholesterol	Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention	14 days
Changes in high sensitivity PCR	Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention	14 days
Changes in HDL cholesterol	Changes in HDL from baseline to end of intervention	14 days
Changes in IL-6	Changes in IL-6, measured in pg/mL, from baseline to end of intervention	14 days
Changes in IL-10	Changes in IL-10, measured in pg/mL, from baseline to end of intervention	14 days
Changes in TNFa	Changes in TNFa, measured in pg/mL, from baseline to end of intervention	14 days
Changes in adiponectin	Changes in adiponectin, measured in ng/mL, from baseline to end of intervention	14 days
Changes in leptin	Changes in leptin, measured in ng/mL, from baseline to end of intervention	14 days
Changes in triglycerides	Changes in triglycerides, measured in mg/dL, from baseline to end of intervention	14 days
Changes in short chain fatty acids amount in the stool	Changes in short chain fatty acids in the stool, measured in ng/g fecal sample, from baseline to end of intervention	14 days
Changes in alkaline phosphatase activity in the stool	Changes in alkaline phosphatase activity in the stool, measured in xx/xx, from baseline to end of intervention	14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: gut microbiota; inflammatory cytokines; adipokines; short chain fatty acid; arbutus berry; strawberry tree
• Other Study ID Numbers: F4F- Forest for Future

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