Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus

Lupus Erythematosus, Systemic Clinical Trial

Official title:

Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379725
• Other study ID #: IRB202200703
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 22, 2022
• Est. completion date: May 4, 2025

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).

Description:

Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• > 18 years of age

• Able to provide informed consent and undertake study questionnaire completion in English

• Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care

• Be willing and able to comply with all the study-related procedures

Exclusion Criteria:

• Pregnant or planning pregnancy within the duration of the interventional study.

• Currently following a vegetarian/vegan diet.

• Allergy/sensitivity to gluten, soy, or cow's milk.

• Self-disclosure of lactose intolerance

• Inability to comply with the study procedures.

• Baseline dietary fiber intake > 30 g/day

• MEDAS score at baseline > 9

• Baseline consumption of > 2 servings per day of fermented foods

Related Conditions & MeSH terms

• Inflammation
• Lupus Erythematosus, Systemic

Intervention

Other:
• Mediterranean Dietary Pattern
The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.
• High Fermented Food Dietary Pattern
Fermented foods such as yogurt, kefir, fermented cottage cheese, fermented vegetables, vegetable brine drinks, kombucha, other fermented non-alcoholic drinks, and other foods will be recommended.

Locations

Country	Name	City	State
United States	University of Florida/UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence - Mediterranean Diet	Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score	baseline, month 1, 2 and 3
Primary	Adherence - Fermented Food Diet	Percent of participants achieving > 5 servings of fermented foods per day	baseline, month 1, 2, and 3
Secondary	Diet Quality	Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.	baseline, month 3
Secondary	Systemic Lupus Erythematosus Disease Activity	Systemic Lupus Erythematosus disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (0 minimum and 105 maximum, with higher scores representing higher disease activity.	baseline, month 3
Secondary	ESR	Erythrocyte sedimentation rate	baseline, month 3
Secondary	hsCRP	high-sensitivity C-reactive protein	baseline, month 3
Secondary	anti-dsDNA	Anti-double stranded DNA	baseline, month 3
Secondary	Cytokine profile	Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10	baseline, month 3