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LC/HP for Metabolic Syndrome

N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week1 and week 8
Awards & highlights

Study Summary

This trial will investigate whether a low-carb, high-protein diet can improve metabolic function, body composition, gut bacteria composition and quality of life in individuals with spinal cord injury and impaired glucose tolerance or type 2 diabetes.

Eligible Conditions
  • Metabolic Syndrome
  • Spinal Cord
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week1 and week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week1 and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HDL, LDL, total cholesterol and triglycerides
Change in body mass index
Change in glucose tolerance
+2 more
Secondary outcome measures
Change in Spinal Cord Injury-Quality of Life (SCI-QOL) Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LC/HP groupExperimental Treatment1 Intervention
Intervention group will receive 8 weeks of LC/HP diet. The daily LC-HP dietary intervention will include ~30% total energy as protein (1.6 g/kg per day) with a carbohydrate-to-protein ratio <1.5 and fat intake set at ~30% of the total energy intake. Dietary fat sources will focus on monounsaturated and polyunsaturated fats, e.g., plant oils and nuts; dietary carbohydrate sources will emphasize whole grains, fruits, vegetables, and legumes; and dietary protein sources will include lean meats, fish, chicken, eggs, and nonfat dairy foods, e.g., fat-free milk and low-fat cheese, consistent with American Diabetes Association and Institute of Medicine guidelines. All LC-HP meals will be provided by UAB Center for Clinical and Translational Sciences (CCTS) Bionutrition Unit and delivered to participants' homes 3 times/week (a sample menu is included in Appendix J). Every delivery will include breakfast, lunch, dinner, and snacks for 2 to 3 days.
Group II: ControlActive Control1 Intervention
Control group will not receive the experimental diet and will continue with their usual diets. Participants will complete three 24-hour food recalls (on 2 week days and one day in the weekend) three times (at weeks 1, 4 and 8) during the course of the study to gather dietary information including dietary intake and/or particular aspects of the diet. Participants will be asked to recall foods and beverages they consumed in the 24 hours prior to the interview. Three 24-hour food recalls appear optimal for estimating energy intake.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,683 Total Patients Enrolled
11 Trials studying Metabolic Syndrome
929 Patients Enrolled for Metabolic Syndrome
University of Alabama at BirminghamLead Sponsor
1,589 Previous Clinical Trials
2,280,294 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
231 Patients Enrolled for Metabolic Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Low Carbohydrate/High Protein Diet to Improve Metabolic Health
Ceren Yarar-Fisher 2017. "Low Carbohydrate/High Protein Diet to Improve Metabolic Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03207841.
~8 spots leftby Apr 2025
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