Diet HabitCULTIVARNCT05705960
Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
A study testing Chestnut in people with Diet Habit, run by Universidade Nova de Lisboa at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Chestnut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Nov 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian.
- Filling informed consent.
- Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Nova Medical School Universidade Nova de Lisboa
Lisbon
Catarina Rodrigues, Msc
Inês Mota, Bsc
About this study
Official title: The Effect of Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
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.
Read more
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.
- Conditions
- Diet Habit
- Being tested
- Chestnut
- Keywords
- Chestnut, Gut microbiota diversity, Short chain fatty acid, Lipid
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChestnutOther
Daily consumption of roasted chestnut (150g) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Chestnut | Experimental | Not described Receives: Other: Chestnut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut microbiota characterization
Difference in Gut microbiota taxonomic characterization, from baseline to the end of intervention
Measured: 14 days
Changes in Gut microbiota diversity
Difference in Gut microbiota Shannon index, from baseline to the end of intervention
Measured: 14 days
Secondary outcomes (15)
Changes in fasting glucose
Changes in fasting glucose, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in HOMA-IR
Changes in HOMA-IR from baseline to end of intervention
Measured: 14 days
Changes in total cholesterol
Changes in total cholesterol, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in LDL cholesterol
Changes in LDL cholesterol, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in high sensitivity PCR
Changes in high sensitivity PCR, measured in mg/dL, from baseline to end of intervention
Measured: 14 days
Changes in breath H2
Changes in breath H2, measured in ppm, from baseline to end of intervention
Measured: 14 days
Changes in breath CH4
Changes in breath CH4, measured in ppm, from baseline to end of intervention
Measured: 14 days
Changes in fecal butyrate
Changes in fecal butyrate, measured in M, from baseline to end of intervention
Measured: 14 days
Changes in fecal acetate
Changes in fecal acetate, measured in M, from baseline to end of intervention
Measured: 14 days
Changes in fecal ALP
Changes in fecal ALP, measured in mg/g feces, from baseline to end of intervention
Measured: 14 days
Changes in fecal LPS
Changes in fecal LPS, measured in EU/mL , from baseline to end of intervention
Measured: 14 days
Changes in IL-1b
Changes in IL1b, measured in pg/mL , from baseline to end of intervention
Measured: 14 days
Changes in TNFa
Changes in TNFa, measured in pg/mL , from baseline to end of intervention
Measured: 14 days
Changes in adiponectin
Changes in adiponectin, measured in ng/mL , from baseline to end of intervention
Measured: 14 days
Changes in leptin
Changes in leptin, measured in ng/mL , from baseline to end of intervention
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Nov 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
- Responsible party
- Sponsor
- Investigators
- Ana Faria, PhD, Principal investigator, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705960
- Sponsor's protocol ID
- CULTIVAR
- Acronym
- CULTIVAR
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chestnut Consumption on Modulation of Gut Microbiota and Metabolic Parameters
- ClinicalTrials.gov ID
- NCT05705960
- Acronym / sponsor ID
- CULTIVAR / CULTIVAR
- Conditions
- Diet Habit
- Keywords
- Chestnut, Gut microbiota diversity, Short chain fatty acid, Lipid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Associação Centro de Apoio Tecnológico Agro-Alimentar de Castelo Branco (CATAA)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chestnut | Experimental | Other: Chestnut |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Caucasian.
- Filling informed consent.
- Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChestnutDaily consumption of roasted chestnut (150g) for 14 days | Other | Chestnut |
Primary outcome
Changes in Gut microbiota characterization
Time frame: 14 days
Difference in Gut microbiota taxonomic characterization, from baseline to the end of intervention
Changes in Gut microbiota diversity
Time frame: 14 days
Difference in Gut microbiota Shannon index, from baseline to the end of intervention
15 secondary outcomes
Changes in fasting glucose
Time frame: 14 days
Changes in HOMA-IR
Time frame: 14 days
Changes in total cholesterol
Time frame: 14 days
Changes in LDL cholesterol
Time frame: 14 days
Changes in high sensitivity PCR
Time frame: 14 days
Changes in breath H2
Time frame: 14 days
Changes in breath CH4
Time frame: 14 days
Changes in fecal butyrate
Time frame: 14 days
Changes in fecal acetate
Time frame: 14 days
Changes in fecal ALP
Time frame: 14 days
Changes in fecal LPS
Time frame: 14 days
Changes in IL-1b
Time frame: 14 days
Changes in TNFa
Time frame: 14 days
Changes in adiponectin
Time frame: 14 days
Changes in leptin
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Faria, PhD principal investigator
Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chestnut in people with Diet Habit, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Faria, PhD (00351218803033, ana.faria@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut microbiota characterization (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.