Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

Study Overview
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Brief Summary
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The chestnut tree (Castanea sativa Mill.) is a species widely cultivated in Portugal, which is a major producer of chestnuts. Nuts are nutritionally interesting, not only because of their content of vitamins, minerals, and phytochemicals but also of their high fiber content. Fiber, as it is not digested by humans, has a preponderant role in the intestinal microbiota, for its maintenance, and, consequently, has an impact on metabolic status. The inclusion of foods rich in these components, and with extensive local production, can be an excellent strategy for improving the metabolic parameters of the population. The main objective of this single group assignment clinical trial is to evaluate the effect of including roasted chestnuts in the daily diet on the composition and diversity of the intestinal microbiota. It is also intended to evaluate metabolic parameters to determine the impact of this intervention.

Official Title
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The Effect of Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

Conditions
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Diet Habit

Intervention / Treatment
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* Other: Chestnut


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian. Filling informed consent. Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2. Exclusion Criteria: Chestnut sensibility. Chestnut daily consumption in the month before the study initiation. 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 dietary regimen (e.g., vegan). 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chestnut<br> | Other: Chestnut<br>* Daily consumption of roasted chestnut (150g) 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 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 breath H2 | Changes in breath H2, measured in ppm, from baseline to end of intervention | 14 days | 
| Changes in breath CH4 | Changes in breath CH4, measured in ppm, from baseline to end of intervention | 14 days | 
| Changes in fecal butyrate | Changes in fecal butyrate, measured in M, from baseline to end of intervention | 14 days | 
| Changes in fecal acetate | Changes in fecal acetate, measured in M, from baseline to end of intervention | 14 days | 
| Changes in fecal ALP | Changes in fecal ALP, measured in mg/g feces, from baseline to end of intervention | 14 days | 
| Changes in fecal LPS | Changes in fecal LPS, measured in EU/mL , from baseline to end of intervention | 14 days | 
| Changes in IL-1b | Changes in IL1b, 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chestnut, Gut microbiota diversity, Short chain fatty acid, Lipid