Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000270314
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
22/02/2017
Date last updated
25/02/2020
Date data sharing statement initially provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Dietary effects of culinary herbs and spices on body weight in patients on antidepressants and antipsychotics
Scientific title
Examining the dietary effects of culinary herbs and spices in weight management for patients on antidepressants and antipsychotics – A randomized clinical trial
Secondary ID [1] 291184 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 302064 0
Depression 302097 0
Condition category
Condition code
Diet and Nutrition 301697 301697 0 0
Obesity
Mental Health 301721 301721 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One of the most common side effects of antidepressants are largely believed to cause weight gain in their users. This study aims to examine if consuming normal kitchen spices and herbs "4 herb mixture" affects body weight or depression in people who are on antidepressants.


The herb mixture includes: : A mixture of red chili powder, black pepper, ginger, and turmeric

- the dose administered: three times every day.
- the duration of administration: 90 days
Capsules contained 150 mg of each of the four selected herbs and spices to a total of 600 mg herb and spice per capsule and 1800 mg per day




The strategy used to monitor adherence to the intervention is capsule return and a food diary that should be filled out on a daily basis and brought to the research team on the appointments times.
Intervention code [1] 297183 0
Lifestyle
Intervention code [2] 297196 0
Prevention
Comparator / control treatment
Tow Control groups:
1- The first one would be over-weight but non-depressed subjects who take the herb mixture capsule.

Herb Mixture:
The dose administered: once daily.
- the duration of administration: 90 days
- the mode of administration: oral (000 capsule) that has the herb mixture.
-Total of 90 herb capsules over the period of 90 days.

2- The second one would be depressed subjects taking anti-depressants with placebo that has saline and no herb mixture capsule for this group.


Placebo:
the dose administered: once daily.
- the duration of administration: 90 days
- the mode of administration: oral (000 capsule) that has saline.
-Total of 90 herb capsules over the period of 90 days.
Control group
Placebo

Outcomes
Primary outcome [1] 301093 0
Change in body fat assessed using DEXA scan,
Timepoint [1] 301093 0
1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement
Primary outcome [2] 301141 0
Change in body weight assessed using a weight scale
Timepoint [2] 301141 0
1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement
Secondary outcome [1] 331709 0
Change in depression levels assessed using SCID-5
Timepoint [1] 331709 0
1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement
Secondary outcome [2] 331797 0
Change in C-reactive protein levels assessed using blood samples
Timepoint [2] 331797 0
1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement

Eligibility
Key inclusion criteria
Groups that require participants on antidepressants:
1- Age range: 18-54 years
2- People who are diagnosed with depression and are currently on prescribed antidepressants.

Group that requires non-depressed participants:
1- Age range: 18-54 years
2- Healthy over-weight participants who their BMI is between 25-30
Minimum age
18 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are highly dependent on medical care, people with a cognitive impairment, intellectual disability, mental illness, non-English speaking (to ensure ethical consent) will be excluded from the study. People diagnosed with a chronic heart failure, chronic inflammatory disease will be excluded as well due to increased risk and likelihood of medical issues that could affect the result of the study. Women who are currently breastfeeding or pregnant will be excluded as well. People who are currently participating in a similar intervention and those who are unable to attend the appointment (data collection requires physical presence) will be excluded from this study. People who are taking any medication that could cause weight gain will be excluded "except antidepressants.

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 involved contacting the holder of the allocation schedule is at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Samples size calculation for this study has been made by a La Trobe University statistician. Based on previous study and using G power, number of participants has been determined to be 105 to provide 95% power. This allows 10% dropout of participants to see correlation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15313 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 295597 0
University
Name [1] 295597 0
La Trobe University
Country [1] 295597 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 294465 0
None
Name [1] 294465 0
Address [1] 294465 0
Country [1] 294465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296918 0
La Trobe University
Ethics committee address [1] 296918 0
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Ethics committee country [1] 296918 0
Australia
Date submitted for ethics approval [1] 296918 0
20/02/2017
Approval date [1] 296918 0
11/10/2019
Ethics approval number [1] 296918 0

Summary
Brief summary
This proposed study aims to investigate the association between a mixture of herb and how it could affect both body weight and depression in people who are on prescribed antidepressants. The mixture of herbs include red chili powder, black pepper, ginger, and turmeric . With the aid of DEXA scanning and SCID “a test to evaluate depression” this study will aim to examine if consuming the herbs mixture affects body weight or depression. It became a fact that people who are on prescribed antidepressants tend to gain weight. There are some studies in the past that attempted to create a remedy for the problem. None of them have proposed that herbs can be used together with antidepressants to reduce weight gain.

Flyers and posters will be distributed to announce and recruit volunteers between 18 and 54 years old. Pages on on Facebook can be created to announce the trial. Clinical Trials Connect Database will be used as well to recruit with an in-built screening system. Women who are pregnant, people who are highly dependent on medical care, have a cognitive impairment, or intellectual disability will not be included in this study. However, our main target is people who are on antidepressants and suffering from depression. The duration of the study will be three months. During this time, the participants will be asked to use a mixture of four herb. The four herbs are Black pepper, Red chilli powder, Ginger, and Turmeric.
The ability of these herbs to help with weight problems will be examined by using three groups of people. The first is the control group, which comprises of overweight but non-depressed subjects who take only the herb mixture. The second group comprises the depressed subjects who take only antidepressants with placebo. The third group "the main group" comprises of subjects who take the antidepressants together with the herb. Changes in body (weight/body-fat) and depression will be assessed using three main tests that will be repeated monthly; DEXA scanning to see changes in body fat, the Scale to test body weight, SCID to test depression, and Blood samples to see if there is an improvement in the blood inflammatory markers (C-reactive protein CRP).
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72430 0
Dr Chandana Deekshith
Address 72430 0
PhD Student at the the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 72430 0
Australia
Phone 72430 0
+613 9479 5755
Fax 72430 0
Email 72430 0
20526448@students.latrobe.edu.au
Contact person for public queries
Name 72431 0
Jency Thomas
Address 72431 0
Lecturer in the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 72431 0
Australia
Phone 72431 0
+613 9479 5755
Fax 72431 0
Email 72431 0
j.thomas@latrobe.edu.au
Contact person for scientific queries
Name 72432 0
Mark Jois
Address 72432 0
Senior Lecturer in the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 72432 0
Australia
Phone 72432 0
+613 9479 2172
Fax 72432 0
Email 72432 0
M.Jois@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7085Ethical approval  20526448@students.latrobe.edu.au



Results publications and other study-related documents

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