Recruiting

Mediterranean Diet

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT07223255

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis Gastrointestinal Disease

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Mediterranean diet

Study Details

Brief summary:

There is no study to date that has evaluated the impact or effect of a Mediterranean diet in children with CF. The goal of this study would be to help provide better guidance around questions the investigators, as CF care providers continue to receive from patients and families about how to best promote overall health in pediatric cystic fibrosis from a dietary perspective. Currently, the updated nutritional recommendations are variable and broad. Parents continue to search for more concrete guidance about how best to promote long-term health given the ever-increasing life expectancy of cystic fibrosis patients in this new area of advanced therapeutics. Given the changing landscape of the CF care in general, children are less likely to struggle with early life malnutrition, and it is becoming increasingly clear that high fat, high calorie diets are not beneficial nor are necessary for all children with CF.

Conditions

Cystic Fibrosis (CF)

Cystic Fibrosis Gastrointestinal Disease

Study ID

NCT07223255

Start date

Sep 1, 2026

Status verified date

Oct, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female pediatric patient with cystic fibrosis age 3 and older
  • Nutritional status defined as a BMI Z-score of at least -1 or above
  • Confirm diagnosis of CF defined by 2 CF causing mutations on genetic testing or sweat chloride greater than 60 mEq/L
  • Children with pancreatic insufficient CF and on PERT
  • Children with pancreatic sufficient CF not on PERT
  • Child must be on a full, solids based diet
  • Family willing to child adhere to an exclusive Mediterranean style diet for a period of 6 months
  • Child must be able to follow-up at regular CF clinic visits and attend any additional study visits if necessary

Exclusion Criteria:

  • Children with malnutrition
  • Children who require nutritional supplementation via any type of feeding tube
  • Children with poorly controlled CF lung disease
  • Children with advanced CF liver disease
  • Children with a comorbid gastrointestinal disease such as celiac disease, Crohn's disease or other malabsorptive process to be reviewed by PI
  • Children with significant food allergies or other gastrointestinal allergy
  • Family is unwilling to adhere to prescribed dietary intervention

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: med diet

Mediterranean diet

Interventions

Mediterranean diet

Patients enrolled in this study will follow a Mediterranean diet for a 6 month period.

Primary outcome measure

  • Metagenomic sequencing [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Julie L Sanville, MD

603-653-9666Julie.L.Sanville@hitchcock.org

Sarah P Winslow, RN

603-629-1849Sarah.P.Winslow@hitchcock.org

Locations

Dartmouth Health Children's

Recruiting

Manchester, New Hampshire, United States, 03104

Contacts

Julie Sanville L PI, DO

603 653 9666julie.l.sanville@hitchcock.org

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Jul 2, 2026

Last verified

Oct, 2025

Keywords

  • cfmed
  • meddiet
  • meddiet cf
  • mediterannean diet
  • cystic fibrosis
  • CF with Mediterranean diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2026-07-02.