Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
Primary Purpose
Lupus Erythematosus, Systemic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mediterranean Dietary Pattern
High Fermented Food Dietary Pattern
Sponsored by
About this trial
This is an interventional other trial for Lupus Erythematosus, Systemic focused on measuring SLE, Lupus, Mediterranean diet, Fermented food, Inflammation
Eligibility Criteria
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
Sites / Locations
- University of Florida/UF HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mediterranean diet
Fermented food
Arm Description
Participants will receive diet education on adherence to a Mediterranean dietary pattern.
Participants will receive diet education on adherence to a high fermented food dietary pattern.
Outcomes
Primary Outcome Measures
Adherence - Mediterranean Diet
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Adherence - Fermented Food Diet
Percent of participants achieving > 5 servings of fermented foods per day
Secondary Outcome Measures
Diet Quality
Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
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.
ESR
Erythrocyte sedimentation rate
hsCRP
high-sensitivity C-reactive protein
anti-dsDNA
Anti-double stranded DNA
Cytokine profile
Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05379725
Brief Title
Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
Official Title
Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
May 4, 2025 (Anticipated)
Study Completion Date
May 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
SLE, Lupus, Mediterranean diet, Fermented food, Inflammation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm Description
Participants will receive diet education on adherence to a Mediterranean dietary pattern.
Arm Title
Fermented food
Arm Type
Experimental
Arm Description
Participants will receive diet education on adherence to a high fermented food dietary pattern.
Intervention Type
Other
Intervention Name(s)
Mediterranean Dietary Pattern
Intervention Description
The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.
Intervention Type
Other
Intervention Name(s)
High Fermented Food Dietary Pattern
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence - Mediterranean Diet
Description
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Time Frame
baseline, month 1, 2 and 3
Title
Adherence - Fermented Food Diet
Description
Percent of participants achieving > 5 servings of fermented foods per day
Time Frame
baseline, month 1, 2, and 3
Secondary Outcome Measure Information:
Title
Diet Quality
Description
Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
Time Frame
baseline, month 3
Title
Systemic Lupus Erythematosus Disease Activity
Description
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.
Time Frame
baseline, month 3
Title
ESR
Description
Erythrocyte sedimentation rate
Time Frame
baseline, month 3
Title
hsCRP
Description
high-sensitivity C-reactive protein
Time Frame
baseline, month 3
Title
anti-dsDNA
Description
Anti-double stranded DNA
Time Frame
baseline, month 3
Title
Cytokine profile
Description
Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10
Time Frame
baseline, month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy J Dahl, PhD
Phone
3522943707
Email
wdahl@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaylan Hebert, BS
Phone
3522639136
Email
ufnutrition@ifas.ufl.edu
Facility Information:
Facility Name
University of Florida/UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy J Dahl, PhD
Phone
352-294-3707
Email
wdahl@ufl.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3522639136
12. IPD Sharing Statement
Plan to Share IPD
No
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Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
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