Clinical trial NCT05705960: Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
Official title: The Effect of Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet Habit
Keywords: Chestnut
Gut microbiota diversity
Short chain fatty acid
Lipid
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
First posted: 2023-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Gut microbiota characterization
timeFrame: 14 days
measure: Changes in Gut microbiota diversity
timeFrame: 14 days
Secondary outcomes:
measure: Changes in fasting glucose
timeFrame: 14 days
measure: Changes in HOMA-IR
timeFrame: 14 days
measure: Changes in total cholesterol
timeFrame: 14 days
measure: Changes in LDL cholesterol
timeFrame: 14 days
measure: Changes in high sensitivity PCR
timeFrame: 14 days
measure: Changes in breath H2
timeFrame: 14 days
measure: Changes in breath CH4
timeFrame: 14 days
measure: Changes in fecal butyrate
timeFrame: 14 days
measure: Changes in fecal acetate
timeFrame: 14 days
measure: Changes in fecal ALP
timeFrame: 14 days
measure: Changes in fecal LPS
timeFrame: 14 days
measure: Changes in IL-1b
timeFrame: 14 days
measure: Changes in TNFa
timeFrame: 14 days
measure: Changes in adiponectin
timeFrame: 14 days
measure: Changes in leptin
timeFrame: 14 days
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Nova Medical School Universidade Nova de Lisboa
Study officials:
affiliation: Universidade Nova de Lisboa
name: Ana Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References: