Efficacy of Diet on Quality of Life in Multiple Sclerosis

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

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.

Sponsors & Collaborators

• Terry L. Wahls

  lead OTHER

Principal Investigators

• Terry L Wahls, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-10

Primary Completion

2026-09-01

Completion

2026-12-01

Countries

• United States

Study Locations