Nutritional and botanical support for fatigue in burnout: A randomised controlled pilot and feasibility study
Nutritional and botanical support for fatigue in adults with burnout: A randomised controlled pilot and feasibility study
Southern Cross Univerisity
30 participants
Apr 21, 2024
Interventional
Conditions
Summary
The global healthcare workforce has been described as being in a state of burnout since the global pandemic. Burnout is a three-dimensional condition often resulting from chronic work-related stress, encompassing exhaustion or energy depletion, depersonalisation and a sense of ineffectual accomplishment. The aim of this study is to assess whether a combination of nutritional and herbal intervention is effective in individuals experiencing fatigue associated with burnout but who are otherwise healthy. This 10-week randomised, controlled pilot trial comprises four assessment points: baseline, (Study Clinic 1 ) 1 month later (Study Clinic 2), with the final clinic one month later (Study Clinic 3 ) and a follow up (2 weeks post study clinic 3). The primary outcomes are feasibility and safety measures. Secondary outcomes are burnout severity, measured by the Sydney Burnout Measure (three factors: physical fatigue, behaviours dysfunction, emotional) measured monthly, the Warwick-Edinburgh Mental Well-being Scale (measured monthly), the Fatigue Severity Scale (measured monthly), and a Patient-reported Outcome Measure, such as the Patient Specific Scale (measured monthly).
Eligibility
Inclusion Criteria4
- Currently experiencing burnout, as indicated by a score of 50 or higher on the Sydney Burnout Measure (SBM)
- Read, speak, and understand the English language
- Have access to the internet on a computer or smartphone
- Otherwise healthy
Exclusion Criteria9
- People with diagnosed depression, anxiety, schizophrenia, chronic fatigue syndrome, diabetes, heart disease or who have suffered a stroke, or metabolic disorders such as type II diabetes, polycystic ovary syndrome (PCOS), gastrointestinal disease requiring regular use of medications, gallbladder disease, bacterial or viral infections, epilepsy, neurological conditions such as Parkinson’s disease, and progressive diseases such as cancer will not be eligible for the study.
- People taking regular medication including but not limited to anticholinergics, levadopa/carbidopa, anticoagulant medications such as warfarin, antihypertensive medications including calcium channel blockers such as clozapine, other heart medications such as digoxin, antidiabetic medication, anti-inflammatory medications, such as aspirin or non-steroidal anti-inflammatories, or antibiotics or antiviral medications, or being treated for cancer.
- Current or 12-month history of illicit drug abuse, or alcohol problem
- Planned major life changes in the next 3 months (e.g., moving house)
- Participants (male/female) planning to conceiving within the next 3 months or currently pregnant or lactating
- People who have had a change in medication in the last 3 months or expectation to change during the study duration
- People unwilling to cease other nutritional and herbal supplements in the two weeks prior to the study
- People who have had a history of allergy or adverse or undesirable reactions to the intervention ingredients (magnesium, l-glycine, Panax ginseng, Bacopa monnieri, Astragalus membranaceus, Scutellaria baicalensis, Quercetin, Nicotinamide riboside, Zinc, Vitamin C or Vitamin D)
- People who have participated in other clinical trials within 12 weeks before enrolment
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Interventions
The intervention consists of one botanical and nutritional preparation (2 capsules AM) and one nutritional supplement (1 scoop powder PM) or their active controls. Duration 8 weeks. Give Back Health RejuveGen AUST L 396075. Oral hard capsule (size OOel vegecap) with grey-green powder. Dose is two capsules every morning. Each capsule contains Astragalus membranaceus root 200 mg (Equivalent Astragalus membranaceus (Dry) 2 g); Bacopa monnieri whole plant 200 mg (Equivalent: Bacopa monnieri (Dry) 4 g); nicotinamide riboside chloride 50 mg (Equivalent: ribose 25.82 mg); Panax ginseng root 100 mg (Equivalent: Panax ginseng (Dry) 400 mg); quercetin dihydrate 125 mg; Scutellaria baicalensis root 100 mg (Equivalent: Scutellaria baicalensis (Dry) 2 g). Give Back Health MagRelax AUST L 375975. Oral powder (white) where dose is one scoop of a powder (5.3 g) per day which contains 350 mg of magnesium as magnesium citrate plus 3.0 grams L-glycine. Mix one included scoop (5.3 gram) with water and consume immediately. Take 30 mins before bed. Adherence to the intervention will be monitored by return of all supplement bottles/containers at each clinic visit.
Locations(1)
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ACTRN12624000298516