The Effects of the MIND Diet on Oxidative Stress, Inflammation and Neurodegenerative Risk Biomarkers

NCT05982860 | Completed

• 1 other identifier: BARTU 01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

American football is a high-contact sport, also known as a collision sport. American football players are exposed to various magnitudes and frequencies of head impacts throughout the season. Accordingly, during the American football season, there is an increase in biomarkers that may be associated with brain damage and the risk of developing neurodegenerative diseases later in life. In addition, oxidative stress and inflammation can also increase in athletes during the American football season. This study was planned with the thought that the MIND diet, which is beneficial for brain health with its antioxidant and anti-inflammatory effects, may have positive effects on oxidative stress, inflammation and neurodegenerative risk biomarkers in American football players. The goal of this clinical trial is to examine the effects of the MIND diet on oxidative stress, inflammation and neurodegenerative risk biomarkers in American football players. The main question it aims to answer are: • \[Question\] Does the MIND diet lowers or reduce the levels of oxidative stress, inflammation and neurodegenerative risk biomarkers in American football players? Participants will be randomized into 2 groups MIND diet and control group. The current diet of the players in the control group will not be interfered with during the competition period, but the current nutrition of the players in the MIND diet group will be adapted to the MIND diet according to the food groups in the MIND diet components and their consumption frequencies. The players in the MIND diet group will be asked to include the food groups in the MIND diet in their diet in accordance with their consumption frequency. Researchers will compare the MIND diet and control groups to see if the MIND diet improves oxidative stress, inflammation and neurodegenerative risk biomarkers.

Conditions

Neurodegeneration; Inflammation; Oxidative Stress; Diet, Healthy; Diet Habit; Nutrition, Healthy

Keywords

MIND diet; sports nutrition; Dietary habits; Neurodegeneration; Inflammation; Oxidative stress

Outcome Measures

Primary Outcomes (12)

• Tau protein

  A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.

  Before and after the 9-week research.

• NfL (Neurofilament light polypeptide)

  A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.

  Before and after the 9-week research.

• S100B protein

  A biomarker associated with disruption of the blood-brain barrier, neuroinflammation and brain damage caused by repetitive head impact or concussion occurring during American football games and considered an indicator of neurodegenerative risk.

  Before and after the 9-week research.

• BDNF (Brain Derived Neurotrophic Factor)

  A biomarker associated with an important role in reducing neurodegenerative risk and in cellular events occurring in restorative processes against damage that may lead to oxidative stress and neuroinflammation in contact sports such as American football.

  Before and after the 9-week research.

• Telomere

  Due to increased oxidative stress and inflammation, the erosion of telomeres, a biomarker of aging, may occur more rapidly. Damaged mitochondria in American football players can trigger an increase in oxidative stress and inflammation levels, which are the most important triggers of the mechanisms of neurodegenerative disorders, and lead to cell death. Telomere shortening is associated with premature cellular senescence and cell death and is thought to be a biomarker for neurodegenerative damage at the cellular level.

  Before and after the 9-week research.

• Zonulin

  Low serum zonulin levels appear to be a biomarker for increased intestinal permeability and disruption of gastrointestinal barrier integrity. Increased intestinal permeability and disruption of intestinal barrier integrity may also increase already existing neuroinflammation by increasing inflammation.

  Before and after the 9-week research.

• NOX2 (NADPH oxidase)

  A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.

  Before and after the 9-week research.

• 8-OHdG (8- hydroxy-2-deoxyguanosine)

  A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.

  Before and after the 9-week research.

• F2-isoprostanes (F2-isoPs)

  A biomarker of oxidative stress. American football training and competition periods can cause excessive free radical production and cause oxidative stress.

  Before and after the 9-week research.

• hs-CRP (High-sensitivity C-reactive protein)

  A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.

  Before and after the 9-week research.

• IL-6 (Interleukin 6)

  A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.

  Before and after the 9-week research.

• TNF-α (Tumor necrosis factor alpha)

  A biomarker of inflammation. The concentrations of inflammatory biomarkers can increase during American football training and competition periods.

  Before and after the 9-week research.

Secondary Outcomes (3)

• Sleep quality score

  Before and after the 9-week research.

• Quality of life score

  Before and after the 9-week research.

• Dietary inflammatory index (DII) score

  Before and after the 9-week research.

Study Arms (2)

Control (n:18)

NO INTERVENTION

Players in this group will not be given any nutritional advice/intervention. They will maintain their usual eating habits.

MIND diet (n:18)

EXPERIMENTAL

Players in this group will be asked to include the food groups in the MIND diet in their diet in accordance with their consumption frequency. As a result of the interviews with the coaches and experienced athletes, it was learned that the majority of the athletes did not consume the foods such as wine, berries, and fish included in the MIND diet template. Therefore, these foods, which are the main components of the MIND diet, will be provided by the researcher/project in accordance with the recommended frequencies. However, since wine consumption is not frequently preferred in our country due to religious and socio-cultural reasons, ''hardaliye'', a fermented grape juice (100 mL/day), which is easy to consume and has similar nutritional values to wine (resveratrol and ORAC), will be provided. Berries will be supplied in 2 portions/week, and fish (tons) in 1 portion/week.

Behavioral: MIND diet

Interventions

MIND diet BEHAVIORAL

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet has been established by Morris et al. (2015) to improve brain health, and reduce the risk or slow progression of neurodegenerative diseases. In this diet model, which is similar to the Mediterranean diet, the diet score changes according to the frequency of consumption of some foods. The more consumption of foods such as green leafy vegetables, other vegetables, berries, nuts, whole grains, fish (not fried), beans, poultry (not fried), and the limited consumption of butter/margarine, cheese, red meat and products, fast fried foods, and pastries \& sweets ensure more score. Also, regular consumption of wine (1 glass/d) and using olive oil as primary oil in meals increases the score. Berries, fish, and hardaliye (instead of wine) will be supplied to players as well as recommendations for consumption frequencies of food components in MIND diet to increase total score.

MIND diet (n:18)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since only men play American football, our study is based on male gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having played American football for at least 2 years
• ≥18 years old
• Having had a MIND diet score of \< 7.5 points
• Not having any family or cohabitants following the MIND diet
• Providing written informed consent

You may not qualify if:

• \<18 years old
• Having had a MIND diet score of ≥7.5 points
• History of concussion diagnosed in the last 6 months
• use of anti-inflammatory or antioxidant drugs (\>20 days)
• food allergy
• A state of injury that is unable to carry out the study

Sponsors & Collaborators

• Bartu Eren Güneşliol: lead
• Gazi University: collaborator

Study Sites (1)

Duzce University

Düzce, Turkey, 81620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nerve Degeneration; Inflammation; Feeding Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Bartu Gunesliol, Master

  Duzce University

  PRINCIPAL INVESTIGATOR

• Nilufer Tek, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Asiye Dikmen, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study was planned as a randomized controlled trial.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: June 23, 2023
• Primary Completion: August 31, 2023
• Study Completion: June 5, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It is expected that access to the scientific outputs of this research will be provided from 2025 and will be open until 2028.
• Access Criteria: It is planned to be accessible only to international academic staff and researchers.

Locations

TU (1)