Health TrialsbyHealthPanel

Hesperidin RCT in MS

ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwansea University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of Multiple Sclerosis, Aged 18 years or older.

Disqualifiers

Known food allergies, intolerances, or significant gastrointestinal (GI) problems, Participants under the age of 18 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hesperidin

    Dietary supplement

    500 mg/day Hesperidin capsules for 12 weeks

  • Placebo

    Dietary supplement

    Matching maltodextrin capsules for 12 weeks.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: HesperidinActive comparator 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Week 12

Secondary outcomes

1

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.

Time frame
Baseline and Week 12
2

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.

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swansea University

Lead sponsor

BioActor B.V.

Collaborator

Source ClinicalTrials.gov
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