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Trial registered on ANZCTR


Registration number
ACTRN12620000567921
Ethics application status
Approved
Date submitted
5/02/2020
Date registered
15/05/2020
Date last updated
15/05/2020
Date data sharing statement initially provided
15/05/2020
Date results information initially provided
15/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Polyphenols-rich Tropical Fruits on Mental Health Protection - A Clinical Trial among Middle-aged Women
Scientific title
Effects of Polyphenols-rich Tropical Fruits on Mental Health Protection - A Clinical Trial among Middle-aged Women
Secondary ID [1] 300414 0
Nil known
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 316061 0
Poor mental health 316062 0
Condition category
Condition code
Diet and Nutrition 314332 314332 0 0
Other diet and nutrition disorders
Mental Health 314887 314887 0 0
Other mental health disorders
Neurological 314888 314888 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Middle-aged subjects with signs of poor mental health and cognitive status were randomly assigned to received either polyphenols-rich tropical fruit juice TP 3-in-1 (TM) or placebo. A total of 1500 ml/day (divided for 3 intakes per day) of polyphenols-rich TP 3-in-1 juice or placebo would be taken by the subjects for 3 times per week. Study was conducted for a total of 10 weeks. Changes on subjects' mental health and cognitive status was measured during baseline, week 5 and after the supplementation ended. Additionally, measurement on oxidative stress and metabolic changes was measured throughout the intervention period. Researcher, who was a PhD candidate, would send the beverages on a weekly basis to the subjects' houses. Data collection during baseline, week 5 and by the end of intervention period was conducted at Clinical Trial Ward, UKM Medical Centre.
Intervention code [1] 316707 0
Treatment: Other
Intervention code [2] 317104 0
Lifestyle
Comparator / control treatment
TP 3-in-1 juice is a polyphenols-rich tropical fruit juice, which was developed by a research group from Centre for Healthy Aging and Wellness (H-Care), Universiti Kebangsaan Malaysia. The placebo beverage contained no juice or natural polyphenol but was formulated to look and taste like TP 3-in-1™ juice and to provide the same energy content. A total of 1500 ml/day (divided for 3 intakes per day) of polyphenols-rich TP 3-in-1 juice or placebo would be taken by the subjects for 3 times per week. Study was conducted for a total of 10 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 322707 0
Changes in mental health (as assessed using General Health Questionnaire-28)
Timepoint [1] 322707 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Primary outcome [2] 323210 0
Changes in cognitive status (verbal learning) (as assessed using Rey's Auditory Verbal Learning Test)
Timepoint [2] 323210 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Primary outcome [3] 323783 0
Changes in cognitive status (short term memory) (as assessed using Digit Span)
Timepoint [3] 323783 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [1] 379379 0
Changes in cognitive status (attention and concentration) (as assessed using Comprehensive Trail Making Test)
*this is a primary outcome. The primary outcome section only allows maximum of 3 primary outcomes
Timepoint [1] 379379 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [2] 381186 0
Oxidative stress (malondialdehyde (MDA)), as assessed using plasma sample
Timepoint [2] 381186 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [3] 381187 0
Lipid profile (total cholesterol), as assessed using blood sample
Timepoint [3] 381187 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [4] 382878 0
Lipid profile (triglycerides), as assessed using blood sample
Timepoint [4] 382878 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [5] 382879 0
Lipid profile (HDL), as assessed using blood sample
Timepoint [5] 382879 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [6] 382880 0
Lipid profile (LDL), as assessed using blood sample
Timepoint [6] 382880 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [7] 382956 0
Lipid profile (Total cholesterol/HDL), as assessed using blood sample
Timepoint [7] 382956 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [8] 382957 0
Fasting blood glucose
Timepoint [8] 382957 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [9] 382958 0
HbA1C, as assessed using blood sample
Timepoint [9] 382958 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.
Secondary outcome [10] 382959 0
Metabolomics profile (conducted using NMR analysis), as assessed using urine sample
Timepoint [10] 382959 0
Outcomes were measured during baseline, week 5 and by the end of the supplementation period.

Eligibility
Key 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)
Minimum age
45 Years
Maximum age
59 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using odd/even number sequence after the name list of eligible subjects were obtained.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated by using the formula by Zhong (2009) with 80% power and 95% level of confidence. Additionally, mean difference and standard deviation values of 3.67 and 2.78, respectively, were obtained from a previous study by Gunstad et. al (2006) in order to calculate the sample size. After taking into consideration 20% droupout rate, the calculated sample size was 11 for each group.
Repeated measures analysis of variance (ANOVA) was carried out to determine the effects of polyphenols rich TP 3-in-1™ juice consumption at baseline, week 5 and week 10 (time effect), group effect and interaction effect.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22286 0
Malaysia
State/province [1] 22286 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 304836 0
Government body
Name [1] 304836 0
Malaysian Ministry of Science, Technology and Innovation
Address [1] 304836 0
Aras 1-7, Blok C4 & C5, Kompleks C, Pusat Pentadbiran Kerajaan Persekutuan, 62662 Putrajaya, Malaysia
Country [1] 304836 0
Malaysia
Primary sponsor type
Individual
Name
Suzana Shahar
Address
Dietetics Programme, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 305169 0
Individual
Name [1] 305169 0
Hanisah Rosli
Address [1] 305169 0
Faculty of Allied Health Sciences, University of Cyberjaya, Persiaran Bestari, Cyberjaya, 63000 Selangor
Country [1] 305169 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305246 0
Research Ethics Committee, Universiti Kebangsaan Malaysia
Ethics committee address [1] 305246 0
Research Ethics Committee, Universiti Kebangsaan Malaysia, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur
Ethics committee country [1] 305246 0
Malaysia
Date submitted for ethics approval [1] 305246 0
Approval date [1] 305246 0
20/07/2013
Ethics approval number [1] 305246 0
UKM 1.5.3.5/244/NN-084-2013

Summary
Brief summary
Poor mental health has been identified as one of the main health problems among middle aged adults (National Mental Health Registry 2003). Polyphenols, which are a major antioxidants source, have been proven to be beneficial towards the prevention of various diseases including cancer and diabetes and more recently in mental health. The aim of this research is to determine the effectiveness of polyphenols-rich tropical fruit juice towards the improvement of mental health status.
Subjects aged 45 to 59 years who had given consent to this research will be divided into 2 groups; supplementation and placebo groups. Subjects will be interviewed about personal and social information, medical history, lifestyles factors, dietary history questionnaire and food frequency questionnaire (polyphenols). Besides that, mental health status will also be assessed with several questionnaire. Anthropometric measurements and blood pressure will also be conducted. Polyphenols-rich tropical juice or placebo were given to subjects for 3 times a week (1500ml/day) for a period of 10 weeks. Blood test will be conducted at baseline and after supplementation period. A total of 10 mL of blood will be drawn by a trained phlebotomist during each blood test. Metabolomics analysis using urine samples will be conducted during baseline, week 5 and by the end of supplementation period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99754 0
Prof Suzana Shahar
Address 99754 0
Dietetics Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 99754 0
Malaysia
Phone 99754 0
+60392897602
Fax 99754 0
Email 99754 0
suzana.shahar@ukm.edu.my
Contact person for public queries
Name 99755 0
Prof Suzana Shahar
Address 99755 0
Dietetics Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 99755 0
Malaysia
Phone 99755 0
+60392897602
Fax 99755 0
Email 99755 0
suzana.shahar@ukm.edu.my
Contact person for scientific queries
Name 99756 0
Prof Suzana Shahar
Address 99756 0
Dietetics Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 99756 0
Malaysia
Phone 99756 0
+60392897602
Fax 99756 0
Email 99756 0
suzana.shahar@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Subjects already signed informed consent forms, in which it was stated that their personal information will not be shared with the public. Additionally, it was agreed that their personal data will only be used during this clinical trial.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6692 0
Ethical approval
Citation [1] 6692 0
Link [1] 6692 0
Email [1] 6692 0
Other [1] 6692 0
Type [2] 6693 0
Study protocol
Citation [2] 6693 0
Link [2] 6693 0
Email [2] 6693 0
Other [2] 6693 0
Type [3] 6694 0
Informed consent form
Citation [3] 6694 0
Link [3] 6694 0
Email [3] 6694 0
Other [3] 6694 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English 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.