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Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis (HEAL-MS)

2026年5月8日 更新者:New York University Abu Dhabi

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:Youssef Idaghdour, Professor
  • 電話番号:+971561845775
  • メールyi3@nyu.edu

研究場所

      • Abu Dhabi、アラブ首長国連邦
        • Yas Clinic
        • コンタクト:
        • コンタクト:
        • 副調査官:
          • Lev Brylev, MD, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recruitment Rate (Number of Participants Enrolled per Month)
時間枠:From study start (Month 0) to completion of recruitment (approximately Month 12)
Number of eligible participants enrolled into the study per month, calculated from the number of participants who consent and complete baseline assessment.
From study start (Month 0) to completion of recruitment (approximately Month 12)
Retention Rate (Percentage of Participants Completing All Study Assessments)
時間枠:Baseline to 36 weeks (end of follow-up)
Percentage of enrolled participants who complete all four assessment timepoints (baseline, pre-intervention, post-intervention, and 3-month follow-up).
Baseline to 36 weeks (end of follow-up)
Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)
時間枠:Weeks 13-24 (12-week intervention period)
Proportion of prescribed exercise sessions attended (twice-weekly supervised sessions) during the 12-week intervention period.
Weeks 13-24 (12-week intervention period)
Mobile Application Engagement (Average Daily Completion Rate of App-Based Logs)
時間枠:Weeks 13-24 (12-week intervention period)
Average proportion of days participants complete daily logs (including energy, fatigue, mood, sleep, and adherence tracking) via the HEAL MS mobile application.
Weeks 13-24 (12-week intervention period)
Acceptability of HEAL MS Intervention (Participant Satisfaction Score)
時間枠:Week 24 (post-intervention assessment)
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).
Week 24 (post-intervention assessment)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Plasma C-Reactive Protein (CRP) Concentration (mg/L)
時間枠:Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
CRP will be measured using standard clinical blood chemistry assays. Mean change in CRP concentration will be calculated across timepoints to assess systemic inflammation.
Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
Change in Plasma Interleukin-6 (IL-6) Levels (pg/mL)
時間枠:Baseline (Week 0), Week 12, Week 24, Week 36
IL-6 will be quantified using proteomic analysis (Olink platform). Mean change across timepoints will be used to assess inflammatory signaling.
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Plasma Proteomic Profile (Normalized Protein Expression Units)
時間枠:Baseline (Week 0), Week 12, Week 24, Week 36
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.
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)
時間枠:Baseline, Week 12, Week 24, Week 36
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.
Baseline, Week 12, Week 24, Week 36
Change in Perceived Stress Score (Perceived Stress Scale, PSS-10)
時間枠:Baseline (Week 0), Week 12, Week 24, Week 36
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).
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Daily Emotional Wellbeing Score (App-Based Self-Assessment)
時間枠:Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)
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).
Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Youssef Idaghdour, Professor、New York University Abu Dhabi

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年4月15日

一次修了 (推定)

2027年11月15日

研究の完了 (推定)

2027年11月15日

試験登録日

最初に提出

2026年3月26日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

De-identified IPD may be shared upon reasonable request, subject to institutional approvals and data protection regulations. All shared data will be fully anonymized to protect participant confidentiality. Due to the sensitive nature of multi-omics and health-related data, access may be restricted and governed by data use agreements to ensure compliance with ethical and regulatory standards.

試験データ・資料

  1. 研究プロトコル
    情報コメント:Original Grant Application

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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