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Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet

NCT03790436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-31

No results posted yet for this study

Summary

The purpose of this pilot study is to measure adherence and quality of life in adults with intractable epilepsy following the Modified Atkins Diet (MAD) with Betaquik, a ready-to-use medium chain triglyceride (MCT) emulsion, as an adjunct to the MAD.

Conditions

  • Epilepsy
  • Epilepsy Intractable
  • Seizures
  • Seizure Disorder
  • Ketogenic Dieting
  • Ketosis

Interventions

DIETARY_SUPPLEMENT

Betaquik

Study dietitian will advise each participant on target volume of Betaquik (45g MCT, 225mL Betaquik). Consuming too much MCT too quickly may cause gastrointestinal discomfort such as abdominal pain or diarrhea, this is related to its assimilation to the body. Any symptoms that do occur normally resolve in the majority of patients, and with time and persistence, GI tolerance is usually established. Therefore the study dietitian will advise on a gradual systematic introduction to minimize any adverse effects. The daily-tolerated amount will be divided into 3-4 equal portions, taken regularly throughout the day. subjects will be advised to always take Betaquik with food, as part of meals and snacks, to help promote gastrointestinal tolerance. The goal is within the first 4 weeks participants will have reached their tolerated target volume of Betaquik.

Sponsors & Collaborators

  • Vitaflo International, Ltd

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2021-10-30
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790436 on ClinicalTrials.gov