Clinical trial NCT05810922: Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
Official title: Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Keywords: adipokines
arbutus berry
gut microbiota
inflammatory cytokines
short chain fatty acid
strawberry tree
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
First posted: 2023-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in gut microbiota characterization
timeFrame: 14 days
measure: Changes in gut microbiota diversity
timeFrame: 14 days
Secondary outcomes:
measure: Changes in fasting glucose
timeFrame: 14 days
measure: Changes in HOMA-IR
timeFrame: 14 days
measure: Changes in HDL cholesterol
timeFrame: 14 days
measure: Changes in total cholesterol
timeFrame: 14 days
measure: Changes in LDL cholesterol
timeFrame: 14 days
measure: Changes in high sensitivity PCR
timeFrame: 14 days
measure: Changes in IL-6
timeFrame: 14 days
measure: Changes in IL-10
timeFrame: 14 days
measure: Changes in TNFa
timeFrame: 14 days
measure: Changes in adiponectin
timeFrame: 14 days
measure: Changes in leptin
timeFrame: 14 days
measure: Changes in triglycerides
timeFrame: 14 days
measure: Changes in short chain fatty acids amount in the stool
timeFrame: 14 days
measure: Changes in alkaline phosphatase activity in the stool
timeFrame: 14 days
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Nova Medical School Universidade Nova de Lisboa
Study officials:
affiliation: Universidade Nova de Lisboa
name: Ana Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References: