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Feasibility of a Carbohydrate-restricted, High-fat Diet on Head and Neck Squamous Cell Carcinoma Outcomes

NCT04253808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-11-05

No results posted yet for this study

Summary

This study will test the feasibility of a carbohydrate-restricted, high-fat (CRHF) diet intervention in newly diagnosed head and neck squamous cell carcinoma patients who will receive definitive radiation.

Conditions

Interventions

BEHAVIORAL

Carbohydrate-restricted, high-fat diet

Diet composition was \~45% fats, \~30% carbohydrates, and \~25% proteins. Calorie needs were provided according to what the Bioelectrical Impedance (BIA) device gave as required to maintain bodyweight. Sources of macronutrients: * Carbohydrates: from whole grains, dairy products, legumes, fruits, and vegetables. * Fats: from mono- and polyunsaturated fatty acids, including medium- and long-chain fatty acids. * Proteins: plant-based proteins and lean animal-based proteins. All meals were provided to the participants throughout the study period and the diet was provided orally unless the patient was on a feeding tube or a feeding tube is ordered by a physician during the study period. Diet texture was according to patients chewing and swallowing abilities. If the patient is on a feeding tube or intake is insufficient, a formula with similar macronutrient composition + a protein supplement was provided.

BEHAVIORAL

Regular composition diet

The regular composition diet contained approximately 50-52% carbohydrates, 30% fats, and 18-20% proteins

Sponsors & Collaborators

  • Augusta Victoria Hospital, East Jerusalem

    collaborator UNKNOWN

  • University of Illinois at Urbana-Champaign

    lead OTHER

Principal Investigators

  • Anna E Arthur, PhD, MPH · University of Illinois at Urbana-Champaign

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2021-08-10
Completion
2021-08-10

Countries

  • Palestinian Territories

Study Locations

More Related Trials

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 NCT04253808 on ClinicalTrials.gov