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The effect of fruit anthocyanins in participants attending a cognitive rehabilitation group for mild cognitive impairment: A randomised controlled trial.

The effect of a dietary intervention with fruit-derived anthocyanins in participants attending a cognitive rehabilitation group for mild cognitive impairment: A randomised controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001184268
Enrollment
10
Registered
2018-07-17
Start date
2018-03-22
Completion date
2018-10-25
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus placebo, and CRG plus 250mL QGP juice, using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur within ISLHD clinics, with an aim of 72 subjects. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day food record, and blood collection. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.

Interventions

The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus control intervention, and CRG plus 250mL QGP juice daily for 8 weeks (co

The study aims to evaluate the combined effect of a cognitive rehabilitation group (CRG) with intake of Queen Garnet plum (QGP) juice, to optimise cognition in adults with mild cognitive impairment (MCI). Biomedical measures would contribute to an understanding of the mechanisms of action associated with cognitive improvements. The study would include an 8week, doubleblind randomised controlled trial with two arms, CRG plus control intervention, and CRG plus 250mL QGP juice daily for 8 weeks (consumed in one sitting or in smaller doses throughout the day), using MCI patients referred to the ISLHD Geriatric Outpatient Services or Rehabilitation and Medical Psychology Department. Recruitment and research consent of participants will occur within ISLHD clinics, with an aim of 72 subjects. Participants will return the empty bottles in order to assess intervention compliance. Participants will attend a data collection session at baseline, conducted by Clinical Neuropsychologist and a Research Assistant, where participants will undergo the neuropsychological test battery, collection of demographic data, a food frequency questionnaire and instructions for a 4day food record, and blood collection. Across the six weeks of the CRG participants will learn about the functional memory processes of attention/encoding, storage and retrieval in collective educational sessions. The program will present how to apply internal and external techniques and provide strategies to enhance these processes. The groups will be comprised of 4 to 12 subjects, one sessions of 2 hours per week and adherence will be monitored by an attendance log. Subjects will be provided a 24hour Blood Pressure monitoring device, a urine and faecal sample collection kit, and their supplement/placebo to commence. These assessment procedures will be repeated at 8 weeks.

Sponsors

University of Wollongong
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Mild cognitive impairment; (Mini Mental State Examination (MMSE) score of 24-30; memory complaints

Exclusion criteria

Any form of dementia/neurodegenerative condition, are not able to meet the above criteria, their tested IQ is less than 80, they are unable to speak English, have a history of psychiatric (other than mood) disorder, or any other significant neurological history including head injury, epilepsy, or tumour; intake of anti-inflammatory and antibiotics.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026