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Completed

NCT Number: NCT05810922

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

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.

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Key information

Conditions

Diet Habit Behavior Behavior, Animal Feeding Behavior

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Medical School Universidade Nova de Lisboa

Lisbon, 1169-056, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arbutus berry

Other

consumption of 50 g arbutus berry/day or 200 g arbutus berry/day for 14 days

Primary outcomes

  1. Changes in gut microbiota characterization

    Time frame: 14 days

    Difference in gut microbiota taxonomic characterization, from baseline to the end of intervention

  2. Changes in gut microbiota diversity

    Time frame: 14 days

    Difference in gut microbiota Shannon index, from baseline to the end of intervention

Secondary outcomes

  1. Changes in fasting glucose

    Time frame: 14 days

    Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention

  2. Changes in HOMA-IR

    Time frame: 14 days

    Changes in HOMA-IR from baseline to end of intervention

  3. Changes in HDL cholesterol

    Time frame: 14 days

    Changes in HDL from baseline to end of intervention

  4. Changes in total cholesterol

    Time frame: 14 days

    Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention

  5. Changes in LDL cholesterol

    Time frame: 14 days

    Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention

  6. Changes in high sensitivity PCR

    Time frame: 14 days

    Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention

  7. Changes in IL-6

    Time frame: 14 days

    Changes in IL-6, measured in pg/mL, from baseline to end of intervention

  8. Changes in IL-10

    Time frame: 14 days

    Changes in IL-10, measured in pg/mL, from baseline to end of intervention

  9. Changes in TNFa

    Time frame: 14 days

    Changes in TNFa, measured in pg/mL, from baseline to end of intervention

  10. Changes in adiponectin

    Time frame: 14 days

    Changes in adiponectin, measured in ng/mL, from baseline to end of intervention

  11. Changes in leptin

    Time frame: 14 days

    Changes in leptin, measured in ng/mL, from baseline to end of intervention

  12. Changes in triglycerides

    Time frame: 14 days

    Changes in triglycerides, measured in mg/dL, from baseline to end of intervention

  13. Changes in short chain fatty acids amount in the stool

    Time frame: 14 days

    Changes in short chain fatty acids in the stool, measured in ng/g fecal sample, from baseline to end of intervention

  14. Changes in alkaline phosphatase activity in the stool

    Time frame: 14 days

    Changes in alkaline phosphatase activity in the stool, measured in xx/xx, from baseline to end of intervention

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)

Registry information

Acronym: F4F

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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