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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diet Habit

Intervention / Treatment
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* Other: arbutus berry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one group consuming 50 g of arbutus berry/day one group consuming 200 g of arbutus berry/day
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 g arbutus berry<br>consumption of 50 g arbutus berry/day for 14 days | Other: arbutus berry<br>* consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days<br>|
| Experimental: 200 g arbutus berry<br>consumption of 200 g arbutus berry/day for 14 days | Other: arbutus berry<br>* consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days<br>|

What is the study measuring?
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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 HDL cholesterol | Changes in HDL 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipokines, arbutus berry, gut microbiota, inflammatory cytokines, short chain fatty acid, strawberry tree