- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07589062
Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis (HEAL-MS)
HEAL MS: A Culturally Adapted Lifestyle Medicine Intervention Targeting Metabolic and Immune Dysregulation in Multiple Sclerosis Using Multi-Omics Profiling
The goal of this clinical trial is to learn whether a structured lifestyle program can improve health and wellbeing in people living with multiple sclerosis (MS). The program focuses on four areas: nutrition, physical activity, sleep, and stress management. The study will also examine how lifestyle changes affect biological markers related to inflammation, metabolism, and immune function.
The main questions the study aims to answer are:
Can a 12-week lifestyle program improve fatigue, physical function, sleep, and quality of life in people with MS? Do lifestyle changes influence biological markers related to inflammation, metabolism, and mitochondrial function?
Participants will first complete a 12-week observation period to measure their usual lifestyle and health. After this, they will take part in the 12-week HEAL MS lifestyle program.
Participants will:
Attend four assessment visits at Yas Clinic (baseline, before the intervention, after the intervention, and three months later) Participate in two supervised online exercise sessions per week during the 12-week program Follow a structured nutrition plan, with meals provided during the first two weeks Use a mobile application to log daily habits related to exercise, nutrition, sleep, and stress Complete questionnaires and physical tests and provide blood, saliva, and stool samples during assessment visits
Researchers will analyze these data to understand whether lifestyle interventions can support symptom management and overall health in people living with MS.
연구 개요
상세 설명
Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system characterized by neurodegeneration, demyelination, and progressive disability. Although current treatments primarily focus on immune suppression, growing evidence indicates that non-immune mechanisms, including mitochondrial dysfunction, metabolic imbalance, and chronic systemic inflammation, play a significant role in disease progression and symptom burden. Multi-omics studies have identified disruptions in mitochondrial proteins, lipid and amino acid metabolism, and inflammatory signaling pathways in individuals with MS, suggesting that systemic metabolic processes contribute to disease activity and may represent modifiable therapeutic targets.
HEAL MS (Healthy Eating and Active Living for Multiple Sclerosis) was developed to address these upstream biological drivers through a structured lifestyle intervention integrating nutrition, physical activity, sleep optimization, and stress regulation. The program is culturally adapted for the UAE population and delivered through a hybrid model combining in-person onboarding and digital support via a bilingual (Arabic-English) mobile application that facilitates behavioral tracking, education, and participant engagement.
This study is a 24-month pilot interventional study designed to evaluate the feasibility, acceptability, and biological impact of the HEAL MS program in individuals with relapsing-remitting or progressive MS. Thirty participants will be recruited from collaborating MS clinics. The study uses a within-subject design consisting of a 12-week observation (control) period followed by a 12-week lifestyle intervention. Assessments are conducted at four timepoints: baseline, pre-intervention, post-intervention, and three months after completion of the intervention. This design allows each participant to serve as their own control, improving statistical sensitivity and reducing inter-individual variability.
The intervention targets four behavioral domains. Adaptive movement training consists of supervised small-group sessions conducted twice weekly using functional resistance exercises based on bodyweight, resistance bands, and suspension training. Exercises are designed to improve strength, neuromuscular coordination, and mitochondrial resilience while remaining scalable to accommodate MS-related fatigue and mobility limitations. The nutrition component emphasizes anti-inflammatory, nutrient-dense whole foods with a macronutrient distribution of approximately 40% carbohydrates, 30% protein, and 30% fat. Personalized calorie targets are calculated using the Mifflin-St Jeor equation, and participants receive meal delivery during the initial two weeks to facilitate adherence before transitioning to guided self-preparation. Sleep optimization focuses on circadian-aligned behavioral strategies such as consistent sleep schedules, screen-light reduction, and timing of meals and exercise. Stress regulation includes daily breath-based practices, mindfulness exercises, and vagal nerve-stimulating techniques designed to support autonomic balance. Participant engagement and adherence are supported through daily behavioral tracking using the mobile application.
The study integrates biological, clinical, and behavioral outcomes to evaluate the mechanistic impact of the intervention. Blood samples collected at each assessment will undergo routine clinical chemistry testing and high-resolution molecular profiling. Proteomic analysis will be performed using the Olink Reveal platform, enabling multiplex quantification of over 1,000 plasma proteins related to immune signaling, inflammation, oxidative stress, and metabolic regulation. Metabolomic profiling will be conducted using nuclear magnetic resonance spectroscopy to quantify approximately 250 circulating metabolic biomarkers related to mitochondrial function and systemic metabolism.
Additional outcome measures include body composition assessment using multi-frequency bioelectrical impedance analysis, validated functional performance tests (6-minute step test, five-times-sit-to-stand test, and grip strength), and psychometric instruments assessing fatigue, mood, sleep quality, cognitive performance, and quality of life. Wearable monitoring devices will be used to capture sleep duration, activity levels, and heart rate variability as indicators of physiological recovery and autonomic regulation.
By integrating behavioral intervention with high-resolution molecular profiling, HEAL MS aims to generate mechanistic insight into how lifestyle modification influences metabolic, inflammatory, and mitochondrial pathways in MS. Findings from this pilot study will inform the feasibility and design of larger randomized trials investigating lifestyle-based strategies as complementary approaches to disease management.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Natascha Enriquez, MSc
- 전화번호: +971501821961
- 이메일: natasha.enriquez@nyu.edu
연구 연락처 백업
- 이름: Youssef Idaghdour, Professor
- 전화번호: +971561845775
- 이메일: yi3@nyu.edu
연구 장소
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Abu Dhabi, 아랍 에미리트
- Yas Clinic
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연락하다:
- Lev Brylev, MD, PhD
- 전화번호: +971502377993
- 이메일: lev.brylev@adscc.ae
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연락하다:
- Ruqqia Mir, MD
- 전화번호: +971553676270
- 이메일: ruqqia.m@adscc.ae
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부수사관:
- Lev Brylev, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Confirmed MS diagnosis (McDonald criteria)
- EDSS score ≤ 6.5 (i.e., ambulatory with or without assistance)
- Stable disease-modifying therapy for ≥ 3 months
- Age 18-50
- Proficiency in English or Arabic
- Clearance to participate in a structured exercise program
- Ability to walk, sit and stand independently, and perform light-to-moderate movement patterns, even with modifications
- Ability and digital literacy to interact with the bilingual HEAL MS mobile app and
- Access to a computer for participation in online sessions
Exclusion Criteria:
- Significant cognitive impairment affecting app use and comprehension of the intervention
- MS relapse within the past 3 months
- Pregnancy or planned pregnancy
- Unmanaged psychiatric disorders
- Other immune-related or chronic inflammatory or metabolic diseases
- Concurrent enrollment in another lifestyle intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HEAL MS Lifestyle Intervention
Participants first complete a 12-week observation period during which they maintain their usual lifestyle.
This is followed by a 12-week HEAL MS lifestyle intervention targeting four domains: adaptive movement, anti-inflammatory nutrition, sleep optimization, and stress regulation.
The movement component includes twice-weekly supervised online group exercise sessions using scalable functional exercises.
The nutrition component provides personalized meal plans with two weeks of meal delivery to support adherence.
Sleep and stress modules include circadian hygiene strategies, breathwork, and mindfulness practices.
Participants track daily behaviors, wellbeing, and optional wearable data through a bilingual mobile application.
Assessments including blood sampling, body composition, functional fitness testing, and questionnaires are conducted at baseline, pre-intervention, post-intervention, and three months post-intervention.
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The intervention is a 12-week multi-domain lifestyle program.
It targets four behavioral domains: physical activity, nutrition, sleep, and stress regulation.
Participants attend twice-weekly supervised online exercise sessions using scalable functional movements performed with bodyweight, resistance bands, and suspension training.
The nutrition component provides individualized meal plans based on maintenance calories, emphasizing anti-inflammatory, whole-food nutrition with a macronutrient distribution of approximately 40% carbohydrates, 30% protein, and 30% fat.
During the first two weeks, meals are delivered to support adherence.
Sleep optimization focuses on circadian-aligned behaviors such as consistent sleep timing and reduced evening light exposure.
Stress regulation includes daily breathing exercises, mindfulness practices, and vagal nerve-stimulating techniques.
Participants track dadaily behaviors, wellbeing, and wearable data using a billiungual mobile app.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment Rate (Number of Participants Enrolled per Month)
기간: From study start (Month 0) to completion of recruitment (approximately Month 12)
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Number of eligible participants enrolled into the study per month, calculated from the number of participants who consent and complete baseline assessment.
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From study start (Month 0) to completion of recruitment (approximately Month 12)
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Retention Rate (Percentage of Participants Completing All Study Assessments)
기간: Baseline to 36 weeks (end of follow-up)
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Percentage of enrolled participants who complete all four assessment timepoints (baseline, pre-intervention, post-intervention, and 3-month follow-up).
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Baseline to 36 weeks (end of follow-up)
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Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)
기간: Weeks 13-24 (12-week intervention period)
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Proportion of prescribed exercise sessions attended (twice-weekly supervised sessions) during the 12-week intervention period.
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Weeks 13-24 (12-week intervention period)
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Mobile Application Engagement (Average Daily Completion Rate of App-Based Logs)
기간: Weeks 13-24 (12-week intervention period)
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Average proportion of days participants complete daily logs (including energy, fatigue, mood, sleep, and adherence tracking) via the HEAL MS mobile application.
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Weeks 13-24 (12-week intervention period)
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Acceptability of HEAL MS Intervention (Participant Satisfaction Score)
기간: Week 24 (post-intervention assessment)
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Participant-reported satisfaction with the intervention, assessed using a standardized post-intervention questionnaire (e.g., Likert scale rating of overall experience, usability, and perceived benefit).
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Week 24 (post-intervention assessment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Plasma C-Reactive Protein (CRP) Concentration (mg/L)
기간: Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
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CRP will be measured using standard clinical blood chemistry assays.
Mean change in CRP concentration will be calculated across timepoints to assess systemic inflammation.
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Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
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Change in Plasma Interleukin-6 (IL-6) Levels (pg/mL)
기간: Baseline (Week 0), Week 12, Week 24, Week 36
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IL-6 will be quantified using proteomic analysis (Olink platform).
Mean change across timepoints will be used to assess inflammatory signaling.
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Baseline (Week 0), Week 12, Week 24, Week 36
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Change in Plasma Proteomic Profile (Normalized Protein Expression Units)
기간: Baseline (Week 0), Week 12, Week 24, Week 36
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Quantitative proteomic profiling will be performed using the Olink Reveal platform.
A composite score derived from selected proteins related to immune function, oxidative stress, and metabolism will be analyzed using normalized protein expression (NPX) values.
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Baseline (Week 0), Week 12, Week 24, Week 36
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Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)
기간: Baseline, Week 12, Week 24, Week 36
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Metabolomic profiling will be conducted using nuclear magnetic resonance (NMR) spectroscopy, quantifying biomarkers related to lipid metabolism, amino acids, and energy pathways.
Mean changes in selected metabolites will be analyzed.
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Baseline, Week 12, Week 24, Week 36
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Change in Perceived Stress Score (Perceived Stress Scale, PSS-10)
기간: Baseline (Week 0), Week 12, Week 24, Week 36
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Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), a validated measure of perceived stress over the past month (score range: 0-40; higher scores indicate greater perceived stress).
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Baseline (Week 0), Week 12, Week 24, Week 36
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Change in Daily Emotional Wellbeing Score (App-Based Self-Assessment)
기간: Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)
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Emotional wellbeing will be assessed using a daily app-based self-report measure (mood and emotional state), collected using a visual Likert or pictorial (Self-Assessment Manikin-style) scale.
Scores will be averaged over 7-day periods prior to each assessment timepoint (range: 0-4; higher scores indicate worse wellbeing).
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Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Youssef Idaghdour, Professor, New York University Abu Dhabi
간행물 및 유용한 링크
일반 간행물
- Simpson-Yap S, Nag N, Probst Y, Reece JC, Jelinek GA, Neate S. Prospective associations of better quality of the diet with improved quality of life over 7.5 years in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Apr;60:103710. doi: 10.1016/j.msard.2022.103710. Epub 2022 Feb 21.
- Nauta IM, Loughlin KNM, Gravesteijn AS, van Wegen J, Hofman RP, Wilmsen N, Coles E, van Kempen ZLE, Killestein J, van Oosten BW, Strijbis EMM, Uitdehaag BMJ, de Jong BA. A multi-domain lifestyle intervention in multiple sclerosis: a longitudinal observational study. J Neurol. 2025 Jun 24;272(7):476. doi: 10.1007/s00415-025-13196-9.
- Sanchez JMS, DePaula-Silva AB, Libbey JE, Fujinami RS. Role of diet in regulating the gut microbiota and multiple sclerosis. Clin Immunol. 2022 Feb;235:108379. doi: 10.1016/j.clim.2020.108379. Epub 2020 Mar 7. No abstract available.
- Mannino A, Lithander FE, Dunlop E, Hoare S, Shivappa N, Daly A, Phillips M, Pereira G, Sherriff J, Lucas RM, Ponsonby AL, Hebert JR, van der Mei I, Black LJ; Ausimmune Investigator Group. A proinflammatory diet is associated with an increased likelihood of first clinical diagnosis of central nervous system demyelination in women. Mult Scler Relat Disord. 2022 Jan;57:103428. doi: 10.1016/j.msard.2021.103428. Epub 2021 Nov 24.
- Coe S, Tektonidis TG, Coverdale C, Penny S, Collett J, Chu BTY, Izadi H, Middleton R, Dawes H. A cross sectional assessment of nutrient intake and the association of the inflammatory properties of nutrients and foods with symptom severity in a large cohort from the UK Multiple Sclerosis Registry. Nutr Res. 2021 Jan;85:31-39. doi: 10.1016/j.nutres.2020.11.006. Epub 2020 Nov 20.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- HRPP-2025-268
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
연구 데이터/문서
-
연구 프로토콜
정보 댓글: Original Grant Application
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
다발성 경화증에 대한 임상 시험
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Sanko University완전한MULTİPLE SCLEROSİS | BALANCE | 유효성 | 신뢰도터키 (Türkiye)
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