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NCT01915433 · ClinicalTrials.gov registry record · NA
Wahls Paleo Diet and Progressive Multiple Sclerosis
A NA study, sponsored by Terry L. Wahls.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01915433: Completed NA study, sponsored by Terry L. Wahls.
NCT01915433 is a NA study that has completed, run by Terry L. Wahls. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915433, a NA study, has completed, sponsored by Terry L. Wahls.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in bio
Primary Outcome
Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
Interventions
- OTHER Wahls Paleo Plus
- OTHER Wahls Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-11 |
| Phase | NA |
What the finished NCT01915433 record still lists
NCT01915433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Wahls Paleo Plus is the first listed.
NCT01915433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915433 about?
NCT01915433 is a clinical study titled "Wahls Paleo Diet and Progressive Multiple Sclerosis". Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual ...
What is the current status of trial NCT01915433?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2013-07. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01915433?
The interventions under investigation include: Wahls Paleo Plus (OTHER), Wahls Diet (OTHER).
Who is sponsoring clinical trial NCT01915433?
This trial is sponsored by Terry L. Wahls, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915433's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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