30 Participants Needed

Mediterranean Diet for Sickle Cell Disease

(MedSCP Trial)

LT
Overseen ByLisa Tussing-Humphreys, PhD, MS, RD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if switching to a Mediterranean Diet can reduce pain for people with Sickle Cell Disease. Researchers will compare pain levels between participants eating Mediterranean foods and those maintaining their usual diets. Individuals with Sickle Cell Disease who experience chronic pain most days of the week may be suitable for this study. Participants in the Mediterranean diet group will receive ready-made meals. As an unphased trial, this study offers a unique opportunity to explore new dietary approaches to managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Mediterranean Diet is safe for individuals with Sickle Cell Disease?

Research has shown that the Mediterranean Diet is generally safe. This diet includes plenty of fruits, vegetables, whole grains, and healthy fats like olive oil. It is not a new drug or supplement, so it is considered safe because many people already eat this way.

Although specific safety data from clinical trials for this diet in people with Sickle Cell Disease is lacking, its foods are commonly consumed and are part of healthy diets worldwide. Since this diet is not a medication, it does not have the usual side effects that new drugs might have. Instead, it offers a balanced and nutritious way of eating, often recommended for good health.

In summary, the Mediterranean Diet is safe for most people and could help manage Sickle Cell Disease symptoms by improving nutrition.12345

Why are researchers excited about this trial?

The Mediterranean Diet is unique for treating sickle cell disease because it emphasizes whole foods like fruits, vegetables, fish, and healthy fats, which are not typically part of the standard treatment approach. Unlike conventional treatments that often involve medications like hydroxyurea or blood transfusions, the Mediterranean Diet may improve overall health and reduce inflammation naturally. Researchers are excited about this approach because it could offer a non-drug strategy to support patients' well-being and potentially enhance their quality of life.

What evidence suggests that the Mediterranean Diet might be an effective treatment for Sickle Cell Disease?

This trial will compare the effects of the Mediterranean Diet with a Usual Diet for individuals with Sickle Cell Disease. Research suggests that the Mediterranean Diet might help reduce pain for people with this condition. While specific studies have not yet directly linked this diet to pain relief in Sickle Cell Disease, it is known for reducing inflammation. The diet emphasizes fruits, vegetables, whole grains, and healthy fats, which can lower inflammation in the body. Less inflammation might lead to fewer pain episodes, common in Sickle Cell Disease. Early findings in other health conditions show that dietary changes can improve overall health, potentially benefiting those with Sickle Cell Disease.14678

Are You a Good Fit for This Trial?

This trial is for individuals with Sickle Cell Disease who experience chronic pain on most days and do not currently follow a Mediterranean diet. Participants must be able to communicate effectively in English.

Inclusion Criteria

I can speak, read, write, and understand English.
My diet does not follow the Mediterranean guidelines.
I have been diagnosed with Sickle Cell Disease.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a Mediterranean Diet or their usual diet for 4 weeks

4 weeks
Baseline and day 27 or 28 visits

Crossover

Participants switch diets and follow the alternate diet for another 4 weeks

4 weeks
Baseline and day 27 or 28 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mediterranean Diet
Trial Overview The study aims to compare the effects of following a Mediterranean Diet versus their usual diet on pain levels in people with Sickle Cell Disease.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Mediterranean DietExperimental Treatment2 Interventions
Group II: Usual DietActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

NCT06886477 | Sickle Cell, Pain and Mediterranean DietThe goal of this study is to compare pain levels in individuals with Sickle Cell Disease while following the Mediterranean Diet to pain levels while following ...
Sickle Cell Disease: Current Drug Treatments and Functional ...Voxelotor treatment resulted in a statistically significant increase in hemoglobin levels and a concurrent reduction in markers associated with ...
The effects of nutritional supplementation for children and ...The effects of nutritional supplementation for children and adolescents with sickle cell disease: A systematic review and meta-analyses.
A systematic review and meta-analysesRandomized controlled trials (RCT) assessing diet or supplements as complementary therapy for children and adolescents with SCD were included (PROSPERO: ...
Improving Outcomes for Patients With Sickle Cell Disease ...This review discusses why systematic data collection for SCD through population-wide surveillance programs can help to facilitate progress in treatment.
Food Consumption of People with Sickle Cell Anemia in a ...The data reported here showed that the consumption of fresh foods was directly influenced by family income. Inadequate food and nutrition intake ...
Association of Food Insecurity With Disease‐Related ...The rates of food insecurity among sampled households of pediatric and young adult patients with SCD were much higher than national (13.4%) and ...
The INFLUENCE OF NUTRITION ON DISEASE SEVERITY ...Under-nourished patients had significantly higher SCD severity scores, frequent SCD related hospitalizations, higher mortality rates, and ...
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