Multiple SclerosisNECTAR-MSNCT07452562
Hesperidin RCT in MS
A study testing Hesperidin in people with Multiple Sclerosis, run by Swansea University at 1 site in United Kingdom.
Trial summary
This study is a randomised, double-blind, placebo-controlled trial investigating the effects of Hesperidin supplementation on cognitive function, fatigue, and stress. Participants will be randomly assigned to receive either 500mg of Hesperidin or a matching placebo daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2026to 18 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Sclerosis, Aged 18 years or older.
Who cannot join
- Known food allergies, intolerances, or significant gastrointestinal (GI) problems, Participants under the age of 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
FHMLS, Nutrition Lab
Swansea, Wales, SA2 8PP
Hayley A Young, PHD, +44 (0) 1792 295908, h.a.young@swansea.ac.uk
About this study
Official title: A Randomized, Placebo-Controlled Trial of Hesperidin for Fatigue,Mood, and Cognitive Function in Multiple Sclerosis
This study is a randomised, double-blind, placebo-controlled trial investigating the effects of Hesperidin supplementation on cognitive function, fatigue, and stress.
Participants will be randomly assigned to receive either 500mg of Hesperidin or a matching placebo daily for 12 weeks. The primary outcome is fatigue, with secondary outcomes including cognitive performance and mood. The trial seeks to determine if this dietary intervention offers symptom-alleviating benefits.
Read the detailed description
Multiple Sclerosis (MS) is a chronic autoimmune condition characterized by neuro-inflammation, oxidative stress, and demyelination, often resulting in debilitating fatigue and cognitive dysfunction. While disease-modifying therapies exist, there is a significant need for accessible, low-risk adjunct interventions to manage these daily symptoms.
Hesperidin is a flavanone found primarily in citrus fruits (e.g., oranges, lemons). Preclinical research using Experimental Autoimmune Encephalomyelitis (EAE)-the standard animal model for MS-has demonstrated that hesperidin supplementation can reduce disease severity and incidence, likely due to its potent anti-inflammatory and antioxidant properties. However, there is a paucity of randomized controlled trials translating these findings to human MS populations.
Study Design \& Methodology. This study is a remote, randomised, double-blind, placebo-controlled, parallel-group trial in adults with Multiple Sclerosis. Participants will be randomized to receive either 500mg/day of Hesperidin or a matching placebo for a duration of 12 weeks.
Statistical Analysis Plan. Data will be analysed using linear mixed-effects models. For the primary outcome (MFIS total score) and each secondary outcome, change from baseline to week 12 will be compared between intervention and placebo using fixed effects for group, time (baseline, week 12), and the group × time interaction, with a participant-level random intercept. The treatment effect will be estimated from the group × time interaction. Exploratory analyses will test whether baseline habitual diet modifies the intervention effect by adding a diet × group × time interaction term, with habitual diet operationalised using FFQ-derived polyphenol intake (energy-adjusted) and the Dietary Inflammatory Index (DII). In addition, exploratory symptom network analyses will examine whether the pattern of associations among symptoms differs between groups and changes from baseline to week 12.
- Conditions
- Multiple Sclerosis
- Being tested
- Hesperidin, Placebo
- Keywords
- RCT; Hesperidin; Diet
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HesperidinDietary supplement
500 mg/day Hesperidin capsules for 12 weeks
PlaceboDietary supplement
Matching maltodextrin capsules for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hesperidin | Active comparator | Participants receiving Hesperidin capsules for 12 weeks. Receives: Dietary Supplement: Hesperidin |
| Placebo Comparator | Placebo comparator | Participants receiving matching placebo capsules for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS; Fisk et al., 1994), with the MFIS total score as the primary endpoint. MFIS subscale scores (physical, cognitive, psychosocial) and the Fatigue Severity Scale (FSS; Krupp et al., 1989) will be analysed as secondary outcomes to determine effects across different components of fatigue.
Measured: Baseline and Week 12
Secondary outcomes (2)
Mood and Stress
Mood and stress symptoms will be assessed using the Depression Anxiety Stress Scales (DASS). Secondary outcomes will include the Depression, Anxiety, and Stress subscale scores.
Measured: Baseline and Week 12
Cognitive Function Battery
Global cognitive performance will be summarised using a composite score calculated as the mean of standardized (z) scores from a prespecified cognitive battery including: Continuous Performance Task (attention), Auditory Verbal Learning Task (verbal memory), Digit Symbol Substitution Task (speed of information processing), Stroop Task (selective attention/inhibitory control), and Trail Making Task (processing speed/set-shifting). Scores will be coded so that higher values indicate better performance (completion time measures will be reverse-scored prior to standardisation).Individual task outcomes will also be analysed separately to explore domain-specific effects (attention, memory, speed). Fatigue/mood ratings are taken before and after the test to assess cognitive fatigue relating to the tests.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start7 Jan 2026
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor B.V.
- Responsible party
- Principal investigator, Dr Hayley Young, Swansea University
- Investigators
- Hayley A Young, PHD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452562
- Sponsor's protocol ID
- NECTAR-MS
- Acronym
- NECTAR-MS
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial of Hesperidin for Fatigue,Mood, and Cognitive Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07452562
- Acronym / sponsor ID
- NECTAR-MS / NECTAR-MS
- Conditions
- Multiple Sclerosis
- Keywords
- RCT; Hesperidin; Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- BioActor B.V.
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomised, double-blind, placebo-controlled trial investigating the effects of Hesperidin supplementation on cognitive function, fatigue, and stress.
Participants will be randomly assigned to receive either 500mg of Hesperidin or a matching placebo daily for 12 weeks. The primary outcome is fatigue, with secondary outcomes including cognitive performance and mood. The trial seeks to determine if this dietary intervention offers symptom-alleviating benefits.
Detailed description
Multiple Sclerosis (MS) is a chronic autoimmune condition characterized by neuro-inflammation, oxidative stress, and demyelination, often resulting in debilitating fatigue and cognitive dysfunction. While disease-modifying therapies exist, there is a significant need for accessible, low-risk adjunct interventions to manage these daily symptoms.
Hesperidin is a flavanone found primarily in citrus fruits (e.g., oranges, lemons). Preclinical research using Experimental Autoimmune Encephalomyelitis (EAE)-the standard animal model for MS-has demonstrated that hesperidin supplementation can reduce disease severity and incidence, likely due to its potent anti-inflammatory and antioxidant properties. However, there is a paucity of randomized controlled trials translating these findings to human MS populations.
Study Design \& Methodology. This study is a remote, randomised, double-blind, placebo-controlled, parallel-group trial in adults with Multiple Sclerosis. Participants will be randomized to receive either 500mg/day of Hesperidin or a matching placebo for a duration of 12 weeks.
Statistical Analysis Plan. Data will be analysed using linear mixed-effects models. For the primary outcome (MFIS total score) and each secondary outcome, change from baseline to week 12 will be compared between intervention and placebo using fixed effects for group, time (baseline, week 12), and the group × time interaction, with a participant-level random intercept. The treatment effect will be estimated from the group × time interaction. Exploratory analyses will test whether baseline habitual diet modifies the intervention effect by adding a diet × group × time interaction term, with habitual diet operationalised using FFQ-derived polyphenol intake (energy-adjusted) and the Dietary Inflammatory Index (DII). In addition, exploratory symptom network analyses will examine whether the pattern of associations among symptoms differs between groups and changes from baseline to week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hesperidin | Active comparator | Dietary Supplement: HesperidinParticipants receiving Hesperidin capsules for 12 weeks. |
| Placebo Comparator | Placebo comparator | Dietary Supplement: PlaceboParticipants receiving matching placebo capsules for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Multiple Sclerosis, Aged 18 years or older.
Key exclusion criteria (1 listed)
- Known food allergies, intolerances, or significant gastrointestinal (GI) problems, Participants under the age of 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hesperidin500 mg/day Hesperidin capsules for 12 weeks | Dietary supplement | Hesperidin |
| PlaceboMatching maltodextrin capsules for 12 weeks. | Dietary supplement | Placebo Comparator |
Primary outcome
Fatigue
Time frame: Baseline and Week 12
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS; Fisk et al., 1994), with the MFIS total score as the primary endpoint. MFIS subscale scores (physical, cognitive, psychosocial) and the Fatigue Severity Scale (FSS; Krupp et al., 1989) will be analysed as secondary outcomes to determine effects across different components of fatigue.
2 secondary outcomes
Mood and Stress
Time frame: Baseline and Week 12
Cognitive Function Battery
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hayley A Young, PHD principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hesperidin in people with Multiple Sclerosis, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayley Young, PhD (+44 (0) 1792 295908, h.a.young@swansea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.