Ischemic Stroke Nutrition Intervention Study (ISNIS)

Health Effects of Vitamin K2 Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke

The primary goal of this clinical trial is to assess whether vitamin K2 supplementation can effectively improve skeletal muscle and neurological function in patients with ischemic stroke. The main questions it aims to answer are: 1. Does supplementation with vitamin K2 improve the subjects' muscle strength and muscle mass? 2. Can supplementation with vitamin K2 improve the subjects' neurological function after a stroke? Researchers will compare vitamin K2 supplements with a placebo to observe whether vitamin K2 supplementation can improve skeletal muscle and neurological function in patients with ischemic stroke. Participants will: 1. Take vitamin K2 (MK-7) or a placebo daily for 1 year. 2. Attend face-to-face visits and provide biological samples and relevant data at 0, 3, 6, and 12 months. At 9 months, the visit will be online. After the intervention, follow-up will continue for 1 year to observe the long-term effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Dietary supplement: Vitamin K2; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Affiliated Hospital of Harbin Medical University
    • Mudanjiang, Heilongjiang, China, 157000
      • Hongqi Hospital Affiliated to Mudanjiang Medical University
    • Qiqihar, Heilongjiang, China, 161006
      • The Second Affiliated Hospital of Qiqihar Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria：

Participants who meet all the following conditions will be included in the trial:

1. Men or women aged ≥ 18 years.
2. Patients with recent ischemic stroke（first or recurrent stroke no more than 7 days before admission）without significant residual limb paralysis, NIHSS score between 2-15, and muscle strength graded 2-4.
3. The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

Exclusion Criteria：

Participants who meet any of the following conditions will be excluded from the trial:

1. Presence of consciousness disorders, aphasia, or swallowing disorders.
2. The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
3. Coagulation dysfunction or use of vitamin K antagonists.
4. Suffering from chronic gastrointestinal malabsorption (such as celiac disease, short bowel syndrome), severe congestive heart failure, malignant hypertension, severe liver and kidney dysfunction, persistent malignant tumors (continuous treatment, or diagnosis of malignant tumors<5 years), or other related diseases considered by researchers that seriously affect the patient's survival.
5. Having musculoskeletal diseases or cognitive impairment before the stroke.
6. Currently using or planning to use non research approved dietary supplements during the study period.
7. Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
8. Restricted normal eating or currently receiving enteral or parenteral nutrition support.
9. Contraindications for MRI and other examinations.
10. Currently pregnant or planning pregnancy, currently breastfeeding.
11. Participated in a clinical trial using experimental drugs or devices within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin K2; Vitamin K2 (menaquinone-7), 300µg/d, one capsule per day	Dietary supplement: Vitamin K2; Vitamin K2 (MK-7) 300µg/d for 1 year
Placebo Comparator: Placebo Control; Placebo with similar appearance and taste, one capsule per day	Dietary supplement: Placebo; Placebo for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Handgrip strength was measured in participants using an electronic dynamometer.	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained effects of the intervention on handgrip strength	The change in handgrip strength from month 12 (end of intervention) to month 24 (end of follow-up) was assessed. This evaluation aimed to determine the sustained impact of the intervention on handgrip strength following the discontinuation of treatment.	Measurements were recorded at 24 months (end of follow-up).
National Institute of Health Stroke Scale (NIHSS) score	The severity of neurological deficits in participants was evaluated using the National Institutes of Health Stroke Scale (NIHSS). This scale provides a standardized assessment, with total scores ranging from 0 (indicating no deficit) to 42 (representing severe neurological injury).	Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Modified Rankin Scale (mRS) score	The functional neurological recovery of participants will be assessed using the Modified Rankin Scale (mRS). This scale (0-6) quantifies post-stroke disability, where lower scores indicate better outcomes.	Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Mini-Mental State Examination (MMSE) score	The Mini-Mental State Examination (MMSE) will be administered to patients to evaluate cognitive function across multiple domains using a validated 30-point scale (0, severe impairment; 30, intact cognition), with higher scores indicating better cognitive performance.	Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Change in ischemic lesion volume	This study will assess changes in head MRI of patients with ischemic stroke. Change in ischemic lesion volume includes enlargement or reduction of infarcts and the appearance of new ischemic lesions.	Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in white matter lesions	The progression of white matter lesions (especially in high-signal white matter and lesion expansion) will be detected through head MRI.	Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in cerebral blood flow and function	Cerebral blood flow and function (arterial blood supply and other ischemia-related imaging features) will be detected through head MRI.	Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in overall brain structural	The overall brain structural changes (brain atrophy and ventricular enlargement) will be detected through head MRI.	Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Body composition	The body composition of patients will be measured using bioelectrical impedance analysis (BIA).	Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Fugl-Meyer Assessment (FMA) score	The Fugl-Meyer Assessment (FMA) was employed to evaluate motor function in the patient's upper and lower limbs, with total scores ranging from 0 to 100, where higher scores indicate better motor recovery.	Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Functional lower extremity strength	The functional lower extremity strength of patients will be evaluated through the 30-second Chair Stand Test (CST).	Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Gait performance	The gait performance of patients will be measured using 6-meter walk tests.	Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Carotid intima-media thickness (IMT)	The patients will receive carotid artery ultrasonography to quantify carotid intima-media thickness (IMT).	Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Carotid plaques	The patients will undergo carotid artery ultrasonography to detect changes in carotid plaques.	Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Brachial-ankle PWV (baPWV)		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Ankle Brachial Index (ABI)		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Body weight		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Waist circumference		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hip circumference		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Upper arm circumference		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Thigh circumference		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Calf circumference		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Blood pressure (systolic pressure and diastolic pressure)		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Heart rate		Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hospital Anxiety and Depression Scale (HADS）	The Hospital Anxiety and Depression Scale (HADS) was administered to the patients, with the anxiety (HADS-A) and depression (HADS-D) subscales each yielding scores from 0 (asymptomatic) to 21 (severe symptoms).	Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Pittsburgh Sleep Quality Index (PSQI)	The sleep quality of each patient will be evaluated by the Pittsburgh Sleep Quality Index (PSQI), with scores ranging from 0 to 21, with higher scores indicating poorer sleep quality	Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Life quality	The SF-36 assesses 8 health domains (physical or mental function, pain, vitality, etc.) through 36 Likert-scale questions. Scores range from 0 (worst health) to 100 (best health) per domain.	Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Vitamin K2-related biomarkers	Blood samples from the patients will be tested for biomarkers related to vitamin K2 (e.g., serum vitamin K2, dephosphorylated uncarboxylated matrix Gla-protein (dp-ucMGP)).	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Glycemic parameters	Blood samples from the patients will be tested for glycemic parameters (e.g., fasting blood glucose, fasting insulin).	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Lipid metabolism parameters	Blood samples from the patients will be tested for lipid metabolism parameters (e.g., serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)).	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Inflammation-related indicators	Blood samples from the patients will be tested for inflammation-related markers (e.g., IL-1β, IL-6, IL-8, IL-10, TNF-α, TGF-β, TNF-α-induced protein 3 (TNFAIP3), C-reactive protein (CRP)).	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Muscle damage and cardiovascular health-related indicators	Blood samples from the patients will be tested for muscle damage and cardiovascular health indicators (e.g., creatine kinase (CK) and myoglobin (Mb)).	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Blood transcriptomics	Transcriptomic sequencing will be performed on blood samples collected from the patients to observe changes in blood transcriptional levels.	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Metabolomics in serum, urine, and feces	Metabolomic sequencing will be performed on serum, urine, and fecal samples collected from the patients to observe changes in metabolic levels.	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Gut and oral microbiome	Microbiome sequencing will be conducted on fecal and saliva samples collected from the patients.	Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Occurrence of cardiovascular and cerebrovascular events	Cardiovascular and cerebrovascular events of the patients will be monitored during the follow-up.	Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.

Collaborators and Investigators

• Sponsor: Harbin Medical University

Publications and helpful links

General Publications

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• Gely-Pernot A, Coronas V, Harnois T, Prestoz L, Mandairon N, Didier A, Berjeaud JM, Monvoisin A, Bourmeyster N, De Frutos PG, Philippe M, Benzakour O. An endogenous vitamin K-dependent mechanism regulates cell proliferation in the brain subventricular stem cell niche. Stem Cells. 2012 Apr;30(4):719-31. doi: 10.1002/stem.1045.
• Shibata M, Kumar SR, Amar A, Fernandez JA, Hofman F, Griffin JH, Zlokovic BV. Anti-inflammatory, antithrombotic, and neuroprotective effects of activated protein C in a murine model of focal ischemic stroke. Circulation. 2001 Apr 3;103(13):1799-805. doi: 10.1161/01.cir.103.13.1799.
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• Carrie I, Portoukalian J, Vicaretti R, Rochford J, Potvin S, Ferland G. Menaquinone-4 concentration is correlated with sphingolipid concentrations in rat brain. J Nutr. 2004 Jan;134(1):167-72. doi: 10.1093/jn/134.1.167.
• Viegas CS, Rafael MS, Enriquez JL, Teixeira A, Vitorino R, Luis IM, Costa RM, Santos S, Cavaco S, Neves J, Macedo AL, Willems BA, Vermeer C, Simes DC. Gla-rich protein acts as a calcification inhibitor in the human cardiovascular system. Arterioscler Thromb Vasc Biol. 2015 Feb;35(2):399-408. doi: 10.1161/ATVBAHA.114.304823. Epub 2014 Dec 23.
• Lees JS, Chapman FA, Witham MD, Jardine AG, Mark PB. Vitamin K status, supplementation and vascular disease: a systematic review and meta-analysis. Heart. 2019 Jun;105(12):938-945. doi: 10.1136/heartjnl-2018-313955. Epub 2018 Dec 4.
• Mladenka P, Macakova K, Kujovska Krcmova L, Javorska L, Mrstna K, Carazo A, Protti M, Remiao F, Novakova L; OEMONOM researchers and collaborators. Vitamin K - sources, physiological role, kinetics, deficiency, detection, therapeutic use, and toxicity. Nutr Rev. 2022 Mar 10;80(4):677-698. doi: 10.1093/nutrit/nuab061.
• Droujinine IA, Meyer AS, Wang D, Udeshi ND, Hu Y, Rocco D, McMahon JA, Yang R, Guo J, Mu L, Carey DK, Svinkina T, Zeng R, Branon T, Tabatabai A, Bosch JA, Asara JM, Ting AY, Carr SA, McMahon AP, Perrimon N. Proteomics of protein trafficking by in vivo tissue-specific labeling. Nat Commun. 2021 Apr 22;12(1):2382. doi: 10.1038/s41467-021-22599-x.
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Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2025
• Primary Completion (Actual): August 7, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Skeletal Muscle; Vitamin K2; Neurological Function
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Terpenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Diterpenes; Quinones; Vitamin K; Naphthoquinones; Phytol; Vitamin K 2
• Other Study ID Numbers: HMUIRB2024027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No