NCT01538355: IGEL

A Pilot Trial to Test the Feasibility of Prolonged Fasting and Ketogenic Diet in Relapsing-remitting Multiple Sclerosis

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing Prolonged Fasting in Relapsing-Remitting Multiple Sclerosis in 48 participants. Completed in 23 June 2020.

Timeline

30 July 2012

Primary endpoint
28 February 2013

23 June 2020

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	30 July 2012
Primary completion	28 February 2013
Estimated completion	23 June 2020
Sites	1 location across Germany

Drugs / interventions tested

• Prolonged Fasting
• Ketogenic low glycemic load treatment
• Control diet

Conditions studied

• Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 68, any sex, with Relapsing-Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is well accepted that nutrition as an environmental factor is involved in the pathogenesis of multiple sclerosis. But is there a role for prolonged fasting and ketogenic low glycemic load treatment to alter the course of multiple sclerosis (MS)? The investigators think yes there is. Primarily the investigators want to detect if these diets are feasible for MS patients. Therefore the investigators examine the impact of this dietary intervention on the health related quality of life for individuals after 7 days, 3 months and 6 months in compare to baseline. Secondarily the investigators focus on endocrinological and immunological changes after 7 days, 3 months and 6 months in compare to baseline.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms.
   Choi IY, Piccio L, Childress P, Bollman B, et al · · 2016 · cited 379× · PMID 27239035 · DOI 10.1016/j.celrep.2016.05.009
2. Gut Microbiota and Their Neuroinflammatory Implications in Alzheimer's Disease.
   Giau VV, Wu SY, Jamerlan A, An SSA, et al · · 2018 · cited 154× · PMID 30441866 · DOI 10.3390/nu10111765
3. Ketogenic diets attenuate cyclooxygenase and lipoxygenase gene expression in multiple sclerosis.
   Bock M, Karber M, Kuhn H. · · 2018 · cited 48× · PMID 30292675 · DOI 10.1016/j.ebiom.2018.08.057
4. Impact of Dietary Intervention on Serum Neurofilament Light Chain in Multiple Sclerosis.
   Bock M, Steffen F, Zipp F, Bittner S. · · 2022 · cited 36× · PMID 34764215 · DOI 10.1212/nxi.0000000000001102
5. Current status of neuroprotective and neuroregenerative strategies in multiple sclerosis: A systematic review.
   Allanach JR, Farrell JW, Mésidor M, Karimi-Abdolrezaee S. · · 2022 · cited 26× · PMID 33870797 · DOI 10.1177/13524585211008760
6. Breaking the barriers to remyelination in multiple sclerosis.
   Gharagozloo M, Bannon R, Calabresi PA. · · 2022 · cited 19× · PMID 35255453 · DOI 10.1016/j.coph.2022.102194
7. Role of Ketogenic Diets in Multiple Sclerosis and Related Animal Models: An Updated Review.
   Lin WS, Lin SJ, Liao PY, Suresh D, et al · · 2022 · cited 18× · PMID 35679067 · DOI 10.1093/advances/nmac065
8. Dietary protection against the visual and motor deficits induced by experimental autoimmune encephalomyelitis.
   Zyla-Jackson K, Walton DA, Plafker KS, Kovats S, et al · · 2023 · cited 17× · PMID 36937529 · DOI 10.3389/fneur.2023.1113954