40 Participants Needed

Dietary Fat Intake for Spinal Cord Injury

EF
Overseen ByElizabeth Felix, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purposes of the study are to quantify and compare relationships among acute changes in inflammatory markers and evoked pain sensitivity after a high-fat meal (HFM) challenge, compared to a moderate-fat meal challenge, and explore the influence of body composition on these responses, in individuals with chronic spinal cord injury

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment involving dietary fat intake for spinal cord injury?

There is no direct evidence from the provided research articles supporting the effectiveness of dietary fat intake treatments specifically for spinal cord injury. However, one study suggests that dietary choices, like a high-fat diet, can influence metabolic outcomes, which are important for overall health in spinal cord injury patients.12345

Is a high-fat diet generally safe for humans?

Research on high-fat diets in humans shows they are generally safe, but they may increase cholesterol levels, which is a risk factor for heart disease. In studies with healthy individuals, high-fat diets were compared to low-fat diets, and the high-fat diets resulted in higher levels of LDL cholesterol (a type of bad cholesterol).12678

How does dietary fat intake treatment differ from other treatments for spinal cord injury?

This treatment is unique because it focuses on adjusting dietary fat intake, which is not a standard approach for spinal cord injury. Unlike typical treatments that might involve medication or physical therapy, this approach explores how different types and amounts of dietary fat can impact health outcomes, potentially offering a novel way to manage or improve conditions related to spinal cord injury.1791011

Research Team

EF

Elizabeth Felix, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals aged 18-65 with chronic spinal cord injury (SCI) that happened at least two years ago, between C4 and L2 levels, and have varying degrees of impairment. They must speak English and be able to understand the study's risks. People are excluded if they have cognitive issues, systemic inflammation not related to weight, conditions preventing body composition measurement by DXA, vein access problems for blood draws, or if pregnant or imprisoned.

Inclusion Criteria

My spinal cord injury happened over 2 years ago.
My spinal cord injury is between my neck and waist.
My spinal injury is classified between AIS A to D.
See 2 more

Exclusion Criteria

Pregnant women
I have a health condition causing long-term inflammation not related to my weight.
I understand the risks of the study and can give my consent.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meal Challenge

Participants receive a moderate fat meal followed by a high fat meal, or vice versa, approximately seven days apart

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in inflammatory markers and evoked pain sensitivity after meal challenges

1 week

Treatment Details

Interventions

  • High Fat Meal
  • Moderate Fat Meal
Trial OverviewThe study aims to measure how a high-fat meal versus a moderate-fat meal affects pain sensitivity and inflammatory markers in people with SCI. It also looks at how body fat distribution influences these responses after eating different types of meals.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Moderate Fat Meal, Followed by High Fat Meal GroupExperimental Treatment2 Interventions
Participants will receive a moderate fat meal, followed by a high fat meal approximately seven days apart.
Group II: High Fat Meal, Followed by Moderate Fat Meal GroupExperimental Treatment2 Interventions
Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Findings from Research

In a study involving 11 young men, a high-fat, low-carbohydrate (HF) diet led to a significant positive fat balance, indicating that higher dietary fat content promotes body fat storage.
Despite differences in macronutrient composition, total energy expenditure remained similar between the high-carbohydrate (HC) and HF diets, suggesting that diet composition primarily affects nutrient storage rather than overall energy expenditure.
Ad libitum intake of a high-carbohydrate or high-fat diet in young men: effects on nutrient balances.Proserpi, C., Sparti, A., Schutz, Y., et al.[2018]
A high-fat diet (HFD) for 8 weeks led to increased body weight and serum cholesterol in rats, but did not significantly affect neuronal apoptosis or neuroinflammation after traumatic brain injury (TBI) compared to a normal diet (ND).
While both HFD and ND groups experienced TBI-related motor deficits and other neurological changes, the only significant difference between the two diets was in the severity of motor deficits following TBI.
Effects of a High-Fat Diet on Neuroinflammation and Apoptosis in Acute Stage After Moderate Traumatic Brain Injury in Rats.Chong, AJ., Wee, HY., Chang, CH., et al.[2021]
A diet rich in green tea extract (GTE) started three weeks before spinal cord injury (SCI) and continued after injury showed some benefits, such as reduced liver iron accumulation and lower blood glucose levels in rats, indicating a minor hepatoprotective effect.
However, GTE treatment did not prevent significant liver damage or metabolic dysfunction post-SCI, suggesting that while diet may have some positive effects, it is not sufficient to fully protect against the metabolic consequences of spinal cord injury.
Dietary Green Tea Extract Prior to Spinal Cord Injury Prevents Hepatic Iron Overload but Does Not Improve Chronic Hepatic and Spinal Cord Pathology in Rats.Goodus, MT., Sauerbeck, AD., Popovich, PG., et al.[2020]

References

Ad libitum intake of a high-carbohydrate or high-fat diet in young men: effects on nutrient balances. [2018]
Effects of a High-Fat Diet on Neuroinflammation and Apoptosis in Acute Stage After Moderate Traumatic Brain Injury in Rats. [2021]
Dietary Green Tea Extract Prior to Spinal Cord Injury Prevents Hepatic Iron Overload but Does Not Improve Chronic Hepatic and Spinal Cord Pathology in Rats. [2020]
Association between dietary fat content and outcomes in pediatric burn patients. [2021]
Substrate utilization in man: effects of dietary fat and carbohydrate. [2019]
[Food intake of Danes and cardiac risk factors]. [2016]
Prospective, randomized, controlled comparison of the effects of low-fat and low-fat plus high-fiber diets on serum lipid concentrations. [2018]
Low-fat, high-fiber diet favorably affects several independent risk markers of ischemic heart disease: observations on blood lipids, coagulation, and fibrinolysis from a trial of middle-aged Danes. [2018]
Dietary guidelines and patterns of food and nutrient intake in Sweden. [2019]
Satiety and substrate mobilization after oral fat stimulation. [2019]
Effect of the amount and type of dietary fat on cardiometabolic risk factors and risk of developing type 2 diabetes, cardiovascular diseases, and cancer: a systematic review. [2022]