Dietary Fat Intake for Spinal Cord Injury

Overseen By Elizabeth Felix, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Cognitive dysfunction, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different levels of dietary fat intake affect inflammation and pain sensitivity in people with long-term spinal cord injuries. Participants will consume both a high-fat meal and a moderate-fat meal, each separated by about a week. Researchers seek to observe the impact of these meals on inflammation and pain. This trial suits individuals who have had a spinal cord injury for at least two years and have injury levels between the neck and mid-back. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance dietary recommendations for spinal cord injury patients.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that eating a high-fat meal can alter certain immune cells in people with spinal cord injury (SCI). These changes might influence how the body manages inflammation and pain. However, clear information about serious side effects from these meals is lacking.

Research indicates that moderate-fat meals may lead to issues like obesity or poor nutrition for many people with SCI. This suggests their bodies might respond differently to various meals. Yet, strong evidence of serious harmful effects from moderate-fat meals is absent.

Overall, both meal types appear generally safe, but individual reactions can vary based on personal health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different levels of dietary fat intake might affect individuals with spinal cord injuries. Unlike traditional treatments that focus on physical therapy or medication to manage symptoms, this approach examines the impact of nutrition on recovery and health. By testing both high-fat and moderate-fat meal plans, the trial aims to uncover how dietary fats could potentially enhance healing processes or improve quality of life for those with spinal cord injuries. This could open up new, non-invasive strategies for managing the condition.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that high-fat meals can affect individuals with spinal cord injuries by altering food processing and nerve repair. These meals might also increase inflammation, potentially worsening pain. In this trial, participants will receive both high-fat and moderate-fat meals in varying sequences. Meals with a moderate amount of fat might not have these negative effects and are generally considered better for balancing energy and meeting nutritional needs after a spinal cord injury. Overall, a high-fat diet is linked to more problems, while moderate-fat meals might be better for long-term health. ^{3 4 5 6 7}

Who Is on the Research Team?

Elizabeth Felix, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• High Fat Meal
• Moderate Fat Meal

Trial Overview The 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.

How Is the Trial Designed?

Group I: Moderate Fat Meal, Followed by High Fat Meal Group Experimental Treatment 2 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 Group Experimental Treatment 2 Interventions

Participants will receive a high fat meal, followed by a moderate fat meal approximately seven days apart.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a 12-month study involving moderately hypercholesterolemic, nonobese Caucasian men and women, a high-soluble-fiber diet led to a 13% reduction in serum cholesterol, significantly more than the 9% reduction from a low-fat diet and 7% from a usual diet.

The high-fiber group maintained similar dietary fat intake as the low-fat group, indicating that the cholesterol reduction was specifically due to increased soluble fiber intake rather than changes in fat consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, randomized, controlled comparison of the effects of low-fat and low-fat plus high-fiber diets on serum lipid concentrations. Anderson, JW., Garrity, TF., Wood, CL., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Replacing saturated fats with polyunsaturated or monounsaturated fats can significantly lower total and LDL cholesterol levels, which is beneficial for cardiovascular health, especially in men.

There is probable evidence that higher total fat intake is associated with increased body weight, but the relationship between total fat intake and the risk of type 2 diabetes remains inconclusive, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Schwab, U., Lauritzen, L., Tholstrup, T., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 21 healthy middle-aged individuals, a low-fat high-fibre diet (REC diet) significantly reduced LDL cholesterol levels and plasma factor VII coagulant activity compared to a high-fat average Danish diet (DANE diet).

The REC diet also increased fasting triglycerides and improved fibrinolytic activity, suggesting it may lower both atherogenic and thrombogenic risks in individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Food intake of Danes and cardiac risk factors]. Marckmann, P., Sandström, B., Jespersen, J.[2016]

The Nordic and Swedish Nutrition Recommendations suggest limiting saturated fat to about 10% of energy and total fat to 30%, while emphasizing a higher intake of carbohydrates (55-60% of energy) and dietary fiber.

Data from a 1989 Swedish dietary survey revealed that the average diet exceeds these fat recommendations, particularly saturated fat, but some individuals do follow healthier dietary patterns characterized by higher fruit and vegetable consumption and lower intake of fat-rich foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary guidelines and patterns of food and nutrient intake in Sweden. Becker, W.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 944 children with severe burns, those on a low-fat/high-carbohydrate diet (Vivonex T.E.N.) experienced significantly shorter ICU stays and lower rates of sepsis compared to those on a high-fat diet (milk).

Patients on the low-fat diet also showed less organ enlargement and hepatic steatosis at autopsy, suggesting that a high carbohydrate/low fat nutrition approach may lead to better clinical outcomes in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between dietary fat content and outcomes in pediatric burn patients. Lee, JO., Gauglitz, GG., Herndon, DN., et al.[2021]

In a study of 14 young female students, those classified as 'restrained eaters' had a harder time adjusting their fat oxidation when consuming a high-fat diet compared to 'unrestrained eaters', leading to a positive fat balance for the restrained group.

Both restrained and unrestrained eaters showed increased fat and carbohydrate oxidation with higher fat and carbohydrate diets, but restrained eaters had a negative fat balance on a low-fat diet, indicating they oxidized more fat than they consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substrate utilization in man: effects of dietary fat and carbohydrate. Verboeket-van de Venne, WP., Westerterp, KR., ten Hoor, F.[2019]

The study involved 36 participants (26 women and 10 men) who underwent oral fat stimulation using the modified sham feeding technique, which led to increased insulin and glucose levels, indicating a cephalic response lasting up to 90 minutes.

Different types of fats, particularly linoleic oil, significantly enhanced satiety and increased levels of metabolites like triacylglycerol and glycerol compared to water, suggesting that certain fats can effectively stimulate appetite regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satiety and substrate mobilization after oral fat stimulation. Smeets, AJ., Westerterp-Plantenga, MS.[2019]

In a study of 21 healthy middle-aged individuals, a low-fat, high-fiber diet (Rec diet) significantly reduced LDL cholesterol levels and plasma factor VII coagulant activity compared to a high-fat average Danish diet (Dane diet).

The Rec diet not only lowered atherogenic risk factors but also improved fibrinolytic activity, suggesting it may reduce both cholesterol levels and blood clotting tendencies, promoting better cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Marckmann, P., Sandström, B., Jespersen, J.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34103485/

The effects of a high-fat/high-carbohydrate meal on ... The effects of a high-fat/high-carbohydrate meal on leukocyte populations in adults with chronic spinal cord injury. Spinal Cord Ser Cases.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000845

Unraveling Spinal Cord Injury Nutrition: Effects of Diet on ... In summary, both high-fat and HFHS diets can negatively affect metabolism, nerve repair, and immune function in SCI. Although they may provide short-term energy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389429/

Energy expenditure and nutrient intake after spinal cord injury The authors concluded that their findings may explain why persons with tetraplegia had significantly great percentage body fat relative to paraplegia.

4. researchgate.net researchgate.net/publication/352221184_The_effects_of_a_high-fathigh-carbohydrate_meal_on_leukocyte_populations_in_adults_with_chronic_spinal_cord_injury

(PDF) The effects of a high-fat/high-carbohydrate meal on ... To examine the effects of a high-fat/high-carbohydrate meal on leukocyte populations in adults with a chronic SCI. University-based laboratories in British ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825000404

High-fat diet and neuroinflammation: The role of mitochondria The article highlights the pivotal role of mitochondrial dysfunction in driving the neuroinflammation in the setting of HFD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8187471/

The effects of a high-fat/high-carbohydrate meal on leukocyte ... In this study, we measured 11 immune cell phenotypes following an HFHC meal in participants with a chronic SCI. Results suggest that many cells responded ...

7. withpower.com withpower.com/trial/phase-spinal-cord-injuries-7-2022-ff84b

Dietary Fat Intake for Spinal Cord Injury Trial Overview The 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 ...