To eat or not to eat—an exploratory randomized controlled trial on fasting and plant-based diet in rheumatoid arthritis (NutriFast-Study)

Frontiers in Nutrition

Nov 2022

DOI: 10.3389/fnut.2022.1030380

Citations:34

Influential Citations:0

Interventional (Human) Studies

Enhanced Details

Methods

Open-label, monocentric, randomized, controlled, parallel-group, explorative clinical trial in adults with rheumatoid arthritis (RA). 53 participants aged 18–79 (predominantly female) were randomized to fasting plus plant-based diet or a guideline-based anti-inflammatory diet; 50 completed per-protocol analysis (25 per group); participants on stable medication.

Intervention

7-day fasting with daily energy intake of 300–350 kcal via vegetable juices and vegetable broth, followed by an 11-week plant-based diet incorporating time-restricted eating and anti-inflammatory spices.

Results

Primary endpoint (HAQ-DI change to 12 weeks) did not differ between groups (p = 0.663). Within-group improvements were faster with fasting+PBD (HAQ-DI improved by day 7) and later with the control diet. DAS28 improved in both groups by 12 weeks. ACR50 or higher responses were higher with fasting+PBD (9/25) vs control (3/25) by week 12. Weight loss favored fasting+PBD (about 4–5 kg by week 6 and ~3.9 kg by week 12) compared with ~0.8 kg in the control group. Vitamin B12 declined in fasting and PBD arms. Lipids and fasting glucose improved by 3 months in both groups. Conclusion: Fasting followed by a plant-based diet did not provide additional functional benefit over a guideline-based anti-inflammatory diet after 12 weeks, but both approaches improved disease activity and cardiovascular risk factors; faster improvements were seen with the fasting regimen. Larger, longer trials are needed to confirm these findings.

Limitations

Open-label, single-center design; small sample size; COVID-19–related recruitment constraints prevented reaching planned enrollment; baseline HAQ-DI differed between groups; predominantly female participants; limited generalizability to men or more vulnerable patients; no long-term follow-up; variations in concomitant RA therapies and dietary adherence; no blinding of participants or outcome assessors.

Abstract

Background Fasting is beneficial in many diseases, including rheumatoid arthritis (RA), with lasting effects for up to 1 year. However, existing data dates back several decades before the introduction of modern therapeutic modalities. Objective This exploratory RCT compares the effects of a 7-day fast followed by a plant-based diet (PBD) to the effects of the dietary recommendations of the German society for nutrition (Deutsche Gesellschaft für Ernährung, DGE) on RA disease activity, cardiovascular (CV) risk factors, and well-being. Methods In this RCT we randomly assigned 53 RA patients to either a 7-day fast followed by an 11-week PBD or a 12-week standard DGE diet. The primary endpoint was the group change from baseline to 12 weeks on the Health Assessment Questionnaire Disability Index (HAQ-DI). Further outcomes included other disease activity scores, body composition, and quality of life. Results Of 53 RA patients enrolled, 50 participants (25 per group) completed the trial and were included into the per-protocol analysis. The primary endpoint was not statistically significant. However, HAQ-DI improved rapidly in the fasting group by day 7 and remained stable over 12 weeks (Δ-0.29, p = 0.001), while the DGE group improved later at 6 and 12 weeks (Δ-0.23, p = 0.032). DAS28 ameliorated in both groups by week 12 (Δ-0.97, p < 0.001 and Δ-1.14, p < 0.001; respectively), with 9 patients in the fasting but only 3 in the DGE group achieving ACR50 or higher. CV risk factors including weight improved stronger in the fasting group than in the DGE group (Δ-3.9 kg, p < 0.001 and Δ-0.7 kg, p = 0.146). Conclusions Compared with a guideline-based anti-inflammatory diet, fasting followed by a plant-based diet showed no benefit in terms of function and disability after 12 weeks. Both dietary approaches had a positive effect on RA disease activity and cardiovascular risk factors in patients with RA. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT03856190, identifier: NCT03856190. show less