Last reviewed · How we verify
NCT04009005
Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
NA trial testing Therapeutic diet and lifestyle in Clinically Isolated Syndrome in 44 participants. Participants enrolled and being followed up; not accepting new ones.
1 August 2022
Quick facts
| Lead sponsor | Terry L. Wahls |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 May 2020 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 September 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Therapeutic diet and lifestyle
Conditions studied
- Clinically Isolated Syndrome — all drugs for Clinically Isolated Syndrome →
- Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →
Sponsor
Terry L. Wahls
Who can join
Adults 18 to 55, any sex, with Clinically Isolated Syndrome or Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.
Saxby SM, Shemirani F, Crippes LJ, Ehlinger MA, et al · · 2024 · cited 4× · PMID 38222092 · DOI 10.2147/dnnd.s441738 -
Feasibility and assessment of self-reported dietary recalls among newly diagnosed multiple sclerosis: a quasi-experimental pilot study.
Saxby SM, Ehlinger MA, Brooks L, Titcomb TJ, et al · · 2024 · cited 1× · PMID 39464680 · DOI 10.3389/fnut.2024.1369700
Verify or expand the search:
- PubMed search for NCT04009005
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Clinically Isolated Syndrome
Currently open trials in the same condition.
- NCT06455332 — Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome · NA · recruiting
- NCT06274671 — Glymphatic MRI in Clinically Isolated Syndrome · recruiting
- NCT06541626 — Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases · recruiting
- NCT05154370 — China National Registry of Neuro-Inflammatory Diseases · recruiting
- NCT05057676 — Autoimmune Intervention Mastery Course Study · NA · recruiting
Other Terry L. Wahls trials
Trials by the same sponsor.
- NCT07180537 — Creating Health Course Study for People With Rheumatological Conditions · NA · recruiting
- NCT05007483 — Efficacy of Diet on Quality of Life in Multiple Sclerosis · NA · active not recruiting
- NCT05057676 — Autoimmune Intervention Mastery Course Study · NA · recruiting
- NCT03659422 — Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04009005 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Terry L. Wahls
- Last refreshed: 26 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009005.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing