Diet HabitF4FNCT05810922
Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
A study testing arbutus berry in people with Diet Habit, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- arbutus berry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Nov 2022to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian.
- Age between 18 and 50 years.
- Filling informed consent.
- Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Nova Medical School Universidade Nova de Lisboa
Lisbon, 1169-056
About this study
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.
Read the 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.
- Conditions
- Diet Habit
- Being tested
- arbutus berry
- Keywords
- adipokines, arbutus berry, gut microbiota, inflammatory cytokines, short chain fatty acid, strawberry tree
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arbutus berryOther
consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 50 g arbutus berry | Experimental | consumption of 50 g arbutus berry/day for 14 days Receives: Other: arbutus berry |
| 200 g arbutus berry | Experimental | consumption of 200 g arbutus berry/day for 14 days Receives: Other: arbutus berry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota characterization
Difference in gut microbiota taxonomic characterization, from baseline to the end of intervention
Measured: 14 days
Changes in gut microbiota diversity
Difference in gut microbiota Shannon index, from baseline to the end of intervention
Measured: 14 days
Secondary outcomes (14)
Changes in fasting glucose
Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in HOMA-IR
Changes in HOMA-IR from baseline to end of intervention
Measured: 14 days
Changes in HDL cholesterol
Changes in HDL from baseline to end of intervention
Measured: 14 days
Changes in total cholesterol
Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in LDL cholesterol
Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in high sensitivity PCR
Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in IL-6
Changes in IL-6, measured in pg/mL, from baseline to end of intervention
Measured: 14 days
Changes in IL-10
Changes in IL-10, measured in pg/mL, from baseline to end of intervention
Measured: 14 days
Changes in TNFa
Changes in TNFa, measured in pg/mL, from baseline to end of intervention
Measured: 14 days
Changes in adiponectin
Changes in adiponectin, measured in ng/mL, from baseline to end of intervention
Measured: 14 days
Changes in leptin
Changes in leptin, measured in ng/mL, from baseline to end of intervention
Measured: 14 days
Changes in triglycerides
Changes in triglycerides, measured in mg/dL, from baseline to end of intervention
Measured: 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
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start8 Nov 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
- Responsible party
- Sponsor
- Investigators
- Ana Faria, PhD, Principal investigator, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810922
- Sponsor's protocol ID
- F4F- Forest for Future
- Acronym
- F4F
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
- ClinicalTrials.gov ID
- NCT05810922
- Acronym / sponsor ID
- F4F / F4F- Forest for Future
- Conditions
- Diet Habit
- Keywords
- adipokines, arbutus berry, gut microbiota, inflammatory cytokines, short chain fatty acid, strawberry tree
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day
| Arm | Type | Receives |
|---|---|---|
| 50 g arbutus berry | Experimental | Other: arbutus berryconsumption of 50 g arbutus berry/day for 14 days |
| 200 g arbutus berry | Experimental | Other: arbutus berryconsumption of 200 g arbutus berry/day for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caucasian.
- Age between 18 and 50 years.
- Filling informed consent.
- Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arbutus berryconsumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days | Other | 200 g arbutus berry, 50 g arbutus berry |
Primary outcome
Changes in gut microbiota characterization
Time frame: 14 days
Difference in gut microbiota taxonomic characterization, from baseline to the end of intervention
Changes in gut microbiota diversity
Time frame: 14 days
Difference in gut microbiota Shannon index, from baseline to the end of intervention
14 secondary outcomes
Changes in fasting glucose
Time frame: 14 days
Changes in HOMA-IR
Time frame: 14 days
Changes in HDL cholesterol
Time frame: 14 days
Changes in total cholesterol
Time frame: 14 days
Changes in LDL cholesterol
Time frame: 14 days
Changes in high sensitivity PCR
Time frame: 14 days
Changes in IL-6
Time frame: 14 days
Changes in IL-10
Time frame: 14 days
Changes in TNFa
Time frame: 14 days
Changes in adiponectin
Time frame: 14 days
Changes in leptin
Time frame: 14 days
Changes in triglycerides
Time frame: 14 days
Changes in short chain fatty acids amount in the stool
Time frame: 14 days
Changes in alkaline phosphatase activity in the stool
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Faria, PhD principal investigator
Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arbutus berry in people with Diet Habit, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota characterization (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.