Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

Not Applicable

Recruiting

• Conditions: Diet Habit
• Interventions: Other: Chestnut

• Registration Number: NCT05705960
• Lead Sponsor: Universidade Nova de Lisboa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Status Verified: 2023-01
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chestnut	Chestnut	-

Primary Outcome Measures

Name	Time	Method
Changes in Gut microbiota diversity	14 days	Difference in Gut microbiota Shannon index, from baseline to the end of intervention
Changes in Gut microbiota characterization	14 days	Difference in Gut microbiota taxonomic characterization, from baseline to the end of intervention

Secondary Outcome Measures

Name	Time	Method
Changes in breath CH4	14 days	Changes in breath CH4, measured in ppm, from baseline to end of intervention
Changes in IL-1b	14 days	Changes in IL1b, measured in pg/mL , 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 leptin	14 days	Changes in leptin, measured in ng/mL , 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 fecal LPS	14 days	Changes in fecal LPS, measured in EU/mL , from baseline to end of intervention
Changes in HOMA-IR	14 days	Changes in HOMA-IR 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 high sensitivity PCR	14 days	Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention
Changes in fecal acetate	14 days	Changes in fecal acetate, measured in M, 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 breath H2	14 days	Changes in breath H2, measured in ppm, from baseline to end of intervention
Changes in fecal butyrate	14 days	Changes in fecal butyrate, measured in M, from baseline to end of intervention
Changes in fecal ALP	14 days	Changes in fecal ALP, measured in mg/g feces, from baseline to end of intervention
Changes in TNFa	14 days	Changes in TNFa, measured in pg/mL , from baseline to end of intervention

Trial Locations

Locations (1)

Nova Medical School Universidade Nova de Lisboa; 🇵🇹 Lisboa, Portugal