Mediterranean Diet for Cystic Fibrosis

(MedDiet CF Trial)

Not yet recruiting at 1 trial location

Overseen By Sarah P Winslow, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Malnutrition, Feeding tube, Poor lung function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a Mediterranean diet might benefit children with cystic fibrosis (CF), a condition affecting the lungs and digestive system. The researchers aim to provide clearer dietary advice for better long-term health, as traditional high-calorie diets may no longer be necessary. Children diagnosed with CF, who are on a solid food diet and can follow a Mediterranean diet for six months, might be suitable for this study. Participants must attend regular check-ups and additional visits as part of the trial.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve dietary guidelines for children with CF.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on following a Mediterranean diet for six months.

What prior data suggests that the Mediterranean diet is safe for children with cystic fibrosis?

Research has shown that the Mediterranean diet is generally safe and easy to follow. Although specific studies on children with cystic fibrosis (CF) are lacking, the diet has been tested in other groups. For example, a study with middle-aged adults without lung disease found that most participants could follow the Mediterranean diet without issues. This diet includes plenty of fruits, vegetables, whole grains, and healthy fats, which are typically safe and beneficial for most people.

The Mediterranean diet is well-known for its health benefits and is often recommended to improve overall health. As it involves a change in eating habits rather than medication, serious side effects are unlikely. However, since this trial involves children with CF, monitoring their response to the diet change is important. Consulting healthcare providers before starting any new diet is crucial, especially for children with specific health conditions like CF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for cystic fibrosis, which often involve medications to manage symptoms and improve lung function, the Mediterranean diet offers a unique dietary approach. This diet emphasizes whole foods, like fruits, vegetables, whole grains, and healthy fats, which may improve overall health and inflammation. Researchers are excited because it could enhance nutritional status and potentially improve quality of life for people with cystic fibrosis, offering a complementary strategy alongside traditional therapies.

What evidence suggests that the Mediterranean diet might be an effective treatment for cystic fibrosis?

Research has shown that the Mediterranean diet, rich in fruits, vegetables, whole grains, and healthy fats, benefits overall health. Although no specific study has examined its effects on children with cystic fibrosis (CF), related research suggests it can enhance lung health and physical activity. This is promising, as children with CF often require improved lung function. Additionally, teaching children with CF about nutrition has improved their health, indicating dietary changes can be beneficial. While more specific research is needed for CF, the balanced nutrition of the Mediterranean diet, which participants in this trial will follow, might support better health for these children. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children with Cystic Fibrosis (CF) who are seeking dietary guidance to promote long-term health. Specific eligibility criteria have not been provided, so it's important to contact the study organizers for detailed inclusion and exclusion criteria.

Inclusion Criteria

My family and I commit to following a Mediterranean diet for 6 months.

Nutritional status defined as a BMI Z-score of at least -1 or above

Child must be on a full, solids based diet

Exclusion Criteria

My child is malnourished.

My child needs nutritional support through a feeding tube.

My child's cystic fibrosis lung condition is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a 6-month exclusive Mediterranean Diet

6 months

Regular dietary consultations and sample collections

Follow-up

Participants are monitored for changes in gastrointestinal microbiome and inflammation markers

4 weeks

Post-diet assessments and sample collections

What Are the Treatments Tested in This Trial?

Interventions

• Mediterranean Diet

Trial Overview The trial is exploring how a Mediterranean diet affects pediatric CF patients. It aims to provide concrete dietary recommendations, considering the improved life expectancy and changing nutritional needs due to advances in CF care.

How Is the Trial Designed?

Group I: med diet Experimental Treatment 1 Intervention

Mediterranean diet

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223255

Gastrointestinal Response of Pediatric Cystic Fibrosis ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6413220/

Effects of Mediterranean Diet and Physical Activity on ... A few studies showed that both adherence to Mediterranean diet (MedDiet) and physical activity practice have a positive impact on pulmonary ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900725000127

Improving diet quality and nutrient intake in pediatric cystic ... This study contributes to the literature by showing that nutrition education given to mothers for CF children, improves the nutritional status of children and ...

4. withpower.com withpower.com/trial/phase-cystic-fibrosis-2026-8aca9

Mediterranean Diet for Cystic Fibrosis (MedDiet CF Trial) 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 ...

5. cambridge.org cambridge.org/core/journals/british-journal-of-nutrition/article/mediterranean-diet-and-cystic-fibrosis/FF022E456061990144633381309F50AD

Mediterranean diet and cystic fibrosis Adherence to Dietary Recommendations, Nutrient Intake Adequacy and Diet Quality among Pediatric Cystic Fibrosis Patients: Results from the ...

6. semanticscholar.org semanticscholar.org/paper/cba6dfdb041a179bba35d87e3efd44d70b13d959

Mediterranean diet and cystic fibrosis The patients reported were in a relatively good clinical state compared with many reports concerning adult patients in the US and Europe, and the authors ...

7. link.springer.com link.springer.com/article/10.1007/s00394-025-03766-y

Interrelationships between diet quality and health-related ... A longitudinal study (N = 40,096) evaluating European CF registry data reported increases in CF-related diabetes incidences with age (< 10 years ...