Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters

Diet Habit Clinical Trial

— CULTIVAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705960
• Other study ID #: CULTIVAR
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: Universidade Nova de Lisboa
• Contact: Ana Faria, PhD
• Phone: 00351218803033
• Email: ana.faria[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit

Intervention

Other:
• Chestnut
Daily consumption of roasted chestnut (150g) for 14 days

Locations

Country	Name	City	State
Portugal	Nova Medical School Universidade Nova de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gut microbiota characterization	Difference in Gut microbiota taxonomic characterization, from baseline to the end of intervention	14 days
Primary	Changes in Gut microbiota diversity	Difference in Gut microbiota Shannon index, from baseline to the end of intervention	14 days
Secondary	Changes in fasting glucose	Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention	14 days
Secondary	Changes in HOMA-IR	Changes in HOMA-IR from baseline to end of intervention	14 days
Secondary	Changes in total cholesterol	Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention	14 days
Secondary	Changes in LDL cholesterol	Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention	14 days
Secondary	Changes in high sensitivity PCR	Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention	14 days
Secondary	Changes in breath H2	Changes in breath H2, measured in ppm, from baseline to end of intervention	14 days
Secondary	Changes in breath CH4	Changes in breath CH4, measured in ppm, from baseline to end of intervention	14 days
Secondary	Changes in fecal butyrate	Changes in fecal butyrate, measured in M, from baseline to end of intervention	14 days
Secondary	Changes in fecal acetate	Changes in fecal acetate, measured in M, from baseline to end of intervention	14 days
Secondary	Changes in fecal ALP	Changes in fecal ALP, measured in mg/g feces, from baseline to end of intervention	14 days
Secondary	Changes in fecal LPS	Changes in fecal LPS, measured in EU/mL , from baseline to end of intervention	14 days
Secondary	Changes in IL-1b	Changes in IL1b, measured in pg/mL , from baseline to end of intervention	14 days
Secondary	Changes in TNFa	Changes in TNFa, measured in pg/mL , from baseline to end of intervention	14 days
Secondary	Changes in adiponectin	Changes in adiponectin, measured in ng/mL , from baseline to end of intervention	14 days
Secondary	Changes in leptin	Changes in leptin, measured in ng/mL , from baseline to end of intervention	14 days