Arbutus Berry - Intervention Study to Evaluate the Modulation of Intestinal Microbiota and Metabolic Parameters
- Conditions
- Diet Habit
- Interventions
- Other: arbutus berry
- Registration Number
- NCT05810922
- Lead Sponsor
- Universidade Nova de Lisboa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Caucasian.
- Age between 18 and 50 years.
- Filling informed consent.
- Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 g arbutus berry arbutus berry consumption of 50 g arbutus berry/day for 14 days 200 g arbutus berry arbutus berry consumption of 200 g arbutus berry/day for 14 days
- Primary Outcome Measures
Name Time Method Changes in gut microbiota characterization 14 days Difference in gut microbiota taxonomic characterization, from baseline to the end of intervention
Changes in gut microbiota diversity 14 days Difference in gut microbiota Shannon index, from baseline to the end of intervention
- Secondary Outcome Measures
Name Time Method Changes in HDL cholesterol 14 days Changes in HDL from baseline to end of intervention
Changes in adiponectin 14 days Changes in adiponectin, measured in ng/mL, from baseline to end of intervention
Changes in short chain fatty acids amount in the stool 14 days Changes in short chain fatty acids in the stool, measured in ng/g fecal sample, from baseline to end of intervention
Changes in leptin 14 days Changes in leptin, measured in ng/mL, from baseline to end of intervention
Changes in alkaline phosphatase activity in the stool 14 days Changes in alkaline phosphatase activity in the stool, measured in xx/xx, from baseline to end of intervention
Changes in total cholesterol 14 days Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention
Changes in IL-6 14 days Changes in IL-6, measured in pg/mL, from baseline to end of intervention
Changes in triglycerides 14 days Changes in triglycerides, measured in mg/dL, from baseline to end of intervention
Changes in fasting glucose 14 days Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention
Changes in HOMA-IR 14 days Changes in HOMA-IR from baseline to end of intervention
Changes in LDL cholesterol 14 days Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention
Changes in high sensitivity PCR 14 days Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention
Changes in TNFa 14 days Changes in TNFa, measured in pg/mL, from baseline to end of intervention
Changes in IL-10 14 days Changes in IL-10, measured in pg/mL, from baseline to end of intervention
Trial Locations
- Locations (1)
Nova Medical School Universidade Nova de Lisboa
🇵🇹Lisboa, Portugal