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ACTIVE NOT RECRUITING
NCT05007483
NA

Efficacy of Diet on Quality of Life in Multiple Sclerosis

Sponsor: Terry L. Wahls

View on ClinicalTrials.gov

Summary

The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2022-02-10

Completion Date

2026-12-01

Last Updated

2025-09-12

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

BodyBio Balance Oil

nutraceutical supplement

DIETARY_SUPPLEMENT

Kirunal Fish Oil

nutraceutical supplement

DIETARY_SUPPLEMENT

BodyBio PC

nutraceutical supplement

BEHAVIORAL

Modified Paleolithic Elimination diet

1. Complete elimination of all gluten-, dairy-, and egg-containing foods. 2. Increase fruit and vegetable intake to 6-9 servings/day comprising of 2-3 servings each of the following categories: intensely colored, sulfur-rich, and leafy greens. 3. Consume 6-12 ounces/day protein including organ meats and fatty fish. 4. Consume fermented foods daily. 5. Consume daily servings of algae, seaweed, and nutritional yeast.

BEHAVIORAL

Time Restricted Olive Oil Based (TROO) Ketogenic Diet

1. Restriction of dietary carbohydrates to \< 50 grams/day. 2. Use olive oil (cold-pressed extra virgin preferred) to increase fat intake to \>160 grams/day. 3. Consume \<100 grams/day protein. 4. Limit dairy to 2 servings/day of whole fat options (completely exclude reduced fat dairy). 5. Consume at least 3 servings/day non-starchy vegetables.

BEHAVIORAL

Usual diet with Dietary Guidelines for Americans Diet information

1. Limit sodium to \< 2,300 mg/day. 2. Limit added sugar and saturated fat intake to \<10% of kcal/day, respectively. 3. Consume 5 servings of fruits and vegetables per day. 4. Consume 6-9 ounce equivalents/day of grains, making at least half whole grain options. 5. Consume 3 servings of reduced fat dairy per day. 6. Consume 6 ounces/day protein foods.

Locations (1)

Univeristy of Iowa

Iowa City, Iowa, United States