NCT05705960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 20, 2023

Last Update Submit

January 20, 2023

Conditions

Diet Habit

Keywords

ChestnutGut microbiota diversityShort chain fatty acidLipid

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Changes in fasting glucose

    14 days

  • Changes in HOMA-IR

    14 days

  • Changes in total cholesterol

    14 days

  • Changes in LDL cholesterol

    14 days

  • Changes in high sensitivity PCR

    14 days

  • +10 more secondary outcomes

Study Arms (1)

Chestnut

EXPERIMENTAL
Other: Chestnut

Interventions

ChestnutOTHER

Daily consumption of roasted chestnut (150g) for 14 days

Chestnut

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian.
  • Filling informed consent.
  • Body mass index (BMI) between 18,5 kg/m2 and 25 kg/m2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Medical School Universidade Nova de Lisboa

Lisbon, Portugal

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

horse chestnut seed

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Ana Faria, PhD

    Universidade Nova de Lisboa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Faria, PhD

CONTACT

00351218803033ana.faria@nms.unl.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

November 15, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

PT(1)