Effects of Polyphenols-rich Tropical Fruits on Mental Health Protection - A Clinical Trial among Middle-aged Wome

Not Applicable

Completed

• Conditions: Cognitive Decline; Poor mental health; Diet and Nutrition - Other diet and nutrition disorders; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12620000567921
• Lead Sponsor: Suzana Shahar

Brief Summary

Age-related decline in mental health and cognitive function usually starts to show its sign during middle-age and is greatly affected by dietary factors. Polyphenols have recently received attention in its role to improve various health issues related to aging, including decline in mental health and cognitive status. The study aimed to determine the effects of polyphenols-rich TP 3-in-1™ juice in improving mental health, cognitive status, selected biochemical parameters and metabolomics profiles. Middle-aged women with signs of poor mental health and cognitive status were randomised to receive either polyphenols-rich TP 3-in-1™ juice (n=16) or placebo (n=15). Supplementation was given for three days in a week (three times in the day of beverage consumption) for a period of ten weeks. There were significant interaction effects on RAVLT immediate recall and Comprehensive Trail Making Test (CTMT) Trail 4. Metabolomics analysis showed the presence of metabolites related to polyphenols intake and cognitive functions. Early detection of poor mental health and cognitive status is crucial to prevent further decline among the middle-aged adults. Supplementation of TP 3-in-1™ juice for 10 weeks has the potential to improve cognitive status.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-27
• Study Start: 2020-05-15
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

Had poor score in at least three out of the seven categories of mental health (General Health Questionnaire-28) and cognitive status (as assessed using Rey Auditory Verbal Learning Test (RAVLT)

Exclusion Criteria

1. Change of dietary habits for the past 3 months
2. Subjects with history of mental illness (Alzheimer's disease, schizophrenia, history of stroke)
3. Physical disability
4. Pregnant and lactating women
5. Women who are on hormone-replacement therapy
6. Subjects with chronic diseases (eg. diabetes, hypertension, hyperlipidemia, cancer etc)
7. Subjects who took any food supplements or/and regular polyphenols-rich fruits (more than 2 servings/day for the past 3 months prior to the study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in mental health (as assessed using General Health Questionnaire-28) [Outcomes were measured during baseline, week 5 and by the end of the supplementation period. ];Changes in cognitive status (verbal learning) (as assessed using Rey's Auditory Verbal Learning Test)[Outcomes were measured during baseline, week 5 and by the end of the supplementation period. ];Changes in cognitive status (short term memory) (as assessed using Digit Span)[Outcomes were measured during baseline, week 5 and by the end of the supplementation period. ]