An interventional study of MedDiet+ intervention and General dietary recommendations in Diet Interventions, sponsored by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa. Recruiting at 2 sites in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Not applicable, Interventional, and Treatment
The main goal of this trial is to investigate whether a dietary intervention based on a typical Mediterranean Diet enriched with fermented foods (MedDiet+) can impact gut microbiota and RA-related outcomes.
100 RA patients will be recruited at ULS Santa Maria in Lisbon, Portugal, and randomly assigned to either the intervention (MedDiet+) or the control group. The 12-week nutritional intervention will include a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The control group will receive general recommendations for a healthy diet at baseline. The intervention's effects will be assessed by evaluating disease activity, functional status, quality of life, intestinal permeability, endotoxemia, inflammatory biomarkers, intestinal and oral microbiota, serum proteomics, and serum glycome profile characterisation.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 100 is close to the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
The 12-week nutritional intervention includes a personalized dietary plan based on the MedDiet+ pattern, educational resources, food basket deliveries, and clinical culinary workshops, all developed and monitored weekly by registered dietitians. The nutritional plan includes the food portions of each food group in agreement with the MedDiet recommendations for the adult population, complemented with fermented foods including kefir (provided for daily consumption) and kombucha (provided for consumption 2x/week).
Other: MedDiet+ intervention
This group receives a flyer with general recommendations on a healthy diet based on the Portuguese brief guidance for healthy eating in primary health care at baseline
Other: General dietary recommendations
Study arm will consume a Mediterranean like style diet enriched in fermented foods for 12 weeks
Study arm will be given general healthy eating advice at baseline.
DAS28-ESR
Disease Activity Score in 28 Joints Calculated with erythrocyte sedimentation rate (DAS28-ESR), higher scores indicate higher disease activity
Time frame: 12 weeks
EULAR Good or Moderate Response
Proportion of patients achieving moderate or good response based on European Alliance of Associations for Rheumatology (EULAR) criteria; measured with Disease Activity Score using Erythrocyte Sedimentation Rate) (DAS28-ESR\<2.6 (%).
Time frame: 12 weeks
Ultrasound score
i. Change in ultrasound score for 32 joints assessed using a 0-3 scale for grey scale and power Doppler, score (0-3) per joint, higher scores indicate worse disease activity. ii. Proportion of patients achieving a 10% improvement in the ultrasound joint score (%).
Time frame: 12 weeks
DAS28-CRP
Change in Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP), higher scores indicate worse disease activity.
Time frame: 12 weeks
Quality of life
Change in Short Form-36 (SF-36): higher scores indicate better quality of life, score ranging from 0 to 100
Time frame: 12 weeks
Functional status
Change in Health Assessment Questionnaire (HAQ): higher scores indicate greater disability, score ranging from 0 to 3
Time frame: 12 weeks
α- and β- diversity of the gut and oral microbiota
i. Change in α-diversity: changes in alpha diversity between the different groups using the Chao-1 index, Phylogenetic Diversity index, Simpson index, and Shannon index. ii. Change in β-diversity: we will perform Principal Coordinates Analysis (PCoA) using Bray-Curtis dissimilarity, Weighted UniFrac, and Unweighted
Time frame: 12 weeks
Changes in key gut microbial species
i. Change in the relative abundance of Lactobacillus/ Limosilactobacillus and Bifidobacterium, relative abundance in percentage. ii. Change in butyrate-producing species, relativ abundance in percentage. iii. Change in H₂S-producing species, relative abundance in percentage.
Time frame: 12 weeks
Intestinal permeability
Change in the lactulose/mannitol ratio
Time frame: 12 weeks
Endotoxemia
Change in Endotoxemia measured by TLR4 activation in reporter cells
Time frame: 12 weeks
CRP
Change in C-reactive protein (CRP, mg/L)
Time frame: 12 weeks
ESR
Change in erythrocyte sedimentation rate (ESR, mm/hr)
Time frame: 12 weeks
Faecal calprotectin
Change in faecal calprotectin (μg/g)
Time frame: 12 weeks
CD14s
Change in serum soluble CD14 (CD14s, ng/mL)
Time frame: 12 weeks
LBP
Change in lipopolysaccharide-binding protein (LBP, ng/mL)
Time frame: 12 weeks
IFABP
Change in intestinal fatty acids binding protein levels (IFABP, pg/mL)
Time frame: 12 weeks
Lipid Profile
i.Change in triglycerides (mg/dL) ii.Change in total cholesterol (mg/dL) iii.Change in high-density lipoprotein cholesterol (HDL, mg/dL) iv.Change in low-density lipoprotein cholesterol (LDL, mg/dL)
Time frame: 12 weeks
Body composition
Change in body mass index (BMI, kg/m²; weight in kilograms and height in meters will be comined to report BMI in kg/m²)
Time frame: 4 th, 8 th and 12 th weeks
Anthropometric measurements
Change in body mass index and waist circumference
Time frame: 4 th, 8 th and 12 th weeks
Waist circunference
Change in waist circumference (cm)
Time frame: 4 th, 8 th and 12 th weeks
zonulin levels, serum proteomics, and serum glycomics
We will also analyse: i. Change in zonulin levels (ng/mL). ii. Change in serum proteomics. iii. Change in serum glycomics.
Time frame: 12 weeks
Started Jan 2023 (actual). Primary completion is estimated for Sep 2025, 32 months after the start.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 32 months is above that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa