None listed
Conditions
Brief summary
A single site, open-label pilot study to examine the feasibility of a randomised controlled trial of N-Acetylcysteine (NAC) on loss of control eating. All eligible participants will receive NAC orally at a daily dose of 2400 mg for 12 weeks. Outcome assessment will be made at baseline and at 12 week using questionnaires and ecological momentary assessment (EMA)
Interventions
N-Acetylcysteine (NAC) intervention will be taken orally as capsules at a daily dose of 2400 mg for 12 weeks (2 capsules of 600mg, twice daily). The 10-item Medication Adherence Rating Scale as well as pill count at the end of week 6 and 12 will be used to determine compliance with the study medication.
Sponsors
Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Adult (age >18 years) with loss of control eating, defined as at least one episode of loss of control eating in the past month as assessed using the Eating Loss of Control Scale - Negative pregnancy test at baseline for participants of childbearing potential
Exclusion criteria
- Participant with cognitive impairment which will hinder their ability to provide informed consent or to complete the surveys - Participants who are pregnant or lactating or planning to become pregnant during the study - Use of any medication containing N-Acetylcysteine or other contraindicated medications within 4 weeks prior to enrolment, - Known previous hypersensitivity to N-Acetylcysteine - Any serious medical illness that N-Acetylcysteine may adversely affect. - Surgery within the past 28 days - Currently using or planning to use a formal weight loss program during the study
Outcome results
None listed