Time Restricted Olive Oil Based (TROO) Ketogenic Diet for Multiple Sclerosis, Acute Relapsing

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Univeristy of Iowa, Iowa City, IA
Multiple Sclerosis, Acute Relapsing+2 More
Time Restricted Olive Oil Based (TROO) Ketogenic Diet - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
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Study Summary

This study is evaluating whether a diet can improve quality of life for people with multiple sclerosis.

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Eligible Conditions

  • Multiple Sclerosis, Acute Relapsing

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Time Restricted Olive Oil Based (TROO) Ketogenic Diet will improve 2 primary outcomes and 12 secondary outcomes in patients with Multiple Sclerosis, Acute Relapsing. Measurement will happen over the course of baseline.

Baseline to 24 months
Fatigue Severity Scale score (FSS)
baseline
Ocular Coherence tomography
baseline to 24 Months
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
baseline to 24 months
24 hour dietary intake recalls
9 Hole peg board test
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
Brain volume as measured by non contrast magnetic resonance imaging (MRI)
Critical flicker fusion
Hospital Anxiety Depression Scale (HADS)
Low contrast visual acuity
Modified Fatigue Impact Scale (MFIS)
Neurofilament light chain
Timed 25 foot walk test

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Group 3 Control
1 of 3
Group 1 (Modified paleolithic elimination diet).
1 of 3
Group 2 (TROO)
1 of 3
Active Control
Experimental Treatment

This trial requires 156 total participants across 3 different treatment groups

This trial involves 3 different treatments. Time Restricted Olive Oil Based (TROO) Ketogenic Diet is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Group 1 (Modified paleolithic elimination diet).Modified paleolithic elimination diet.
Group 2 (TROO)Time Restricted Olive Oil Based (TROO) Ketogenic Diet
Group 3 ControlUsual diet with Dietary Guidelines for Americans Diet information

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 24 months for reporting.

Closest Location

Univeristy of Iowa - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion

Patient Q&A Section

What causes multiple sclerosis, acute relapsing?

"The exact cause of multiple sclerosis is unknown as is the exact cause of the acute relapsing-remitting subtype of MS. It is not known if multiple sclerosis is a single disease process in both subtypes of the disease. For example, there is a significant overlap of CSF markers of demyelination in SPMS and AQP4+ MS, suggesting that the pathogenesis of AQP4+ and SPMS differ. There is also a significant overlap between those with MS and NMO in terms of anti-aquaporin antibody titres, implying a spectrum of common underlying pathology in the disease process, including SPMS, AQP4+ MS, and AQP4- NMO." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple sclerosis, acute relapsing?

"Signs of MS can include fatigue, loss of coordination of gait and coordination of movement, sensory deficits, new or worsening cognitive disturbances, and visual loss. MS can occur in a single, or in multiple forms, termed relapsing-remitting or progressive." - Anonymous Online Contributor

Unverified Answer

Can multiple sclerosis, acute relapsing be cured?

"Current therapeutic modalities do not guarantee complete remyelination in most RR MS patients. In contrast to remission in RR MS, no complete remission of AR MS has been described. The role of interferons for treatment of this disease must be demonstrated. As of the current literature, there is no evidence regarding any drug that may produce complete remission in AR MS." - Anonymous Online Contributor

Unverified Answer

What is multiple sclerosis, acute relapsing?

"MS is an inflammatory, noninflammatory, and progressive disease, and the relapsing-remitting form affects more than 80% of individuals. It is a chronic disease that creates demyelination. The MS course is variable and can be categorized into chronic MS and acute MS." - Anonymous Online Contributor

Unverified Answer

How many people get multiple sclerosis, acute relapsing a year in the United States?

"About 10,000 cases are diagnosed with new multiple sclerosis a year in the United States.\n[Source: U.S. Dept of Health & Human Services; National Institute of Mental Health MESAM]\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple sclerosis, acute relapsing?

"In our view, the most common treatment for MS, or at least, the most common treatment, is plasmapheresis, which is used if only for the short-term. Since there is presently no cure for MS, there is a strong emphasis on symptom management, and treatments are highly dependent the patient's clinical symptoms. Also, patients can benefit from early treatment, even if there are no clinically proven treatments for MS." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of time restricted olive oil based (troo) ketogenic diet?

"Troo diet seems to confer a good outcome in terms of improvement of both depression and cognitive domains and it is therefore recommended for these patients." - Anonymous Online Contributor

Unverified Answer

Does time restricted olive oil based (troo) ketogenic diet improve quality of life for those with multiple sclerosis, acute relapsing?

"The study showed significant improvements in the MSQ and the S-100 for TKoA. However, the patients still present with fatigue during the acute event period despite the ketogenic dietary regime." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving time restricted olive oil based (troo) ketogenic diet?

"Findings from a recent study indicate that a short-term, high-oil ketogenic diet is likely to be more effective than a moderate-oil ketogenic diet in patients with multiple sclerosis. The higher the-to--low levels of serum S1P in patients with more active MS, these data may provide a useful marker for the effectiveness of the ketogenic diet for this disorder." - Anonymous Online Contributor

Unverified Answer

Has time restricted olive oil based (troo) ketogenic diet proven to be more effective than a placebo?

"In a recent study, findings confirmed that a 3-year treatment with TKRD was effective in reducing seizure frequency in young and adult patients. TKRD is a viable option as a long-term treatment to be considered in addition to conventional treatments as it can be easily administered in the outpatient setting. Future prospective randomized studies and longer term trials are required to better define the TKRD effectiveness as a long-term treatment of focal or myoclonic epilepsy." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple sclerosis, acute relapsing?

"We found the average age someone gets AIM was 46.9.  Age is definitely correlated to disease progression and disability, but it makes sense that the younger the patient is more healthy and active, and thus has a higher risk of developing MS.  The average age of AIM onset is a factor that plays into treatment plan options for AIM, and when is its best to detect it early on, so it is best to prevent MS from worsening." - Anonymous Online Contributor

Unverified Answer

Does multiple sclerosis, acute relapsing run in families?

"Acute relapsing relapsing remitting MS run in families. Many of the relatives are not carriers of the disease, yet have symptoms and signs of advanced disease that could be prevented by therapy that is available to patients. Recent findings may have important clinical implications for the management of patients and their relatives." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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