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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Depression

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

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]

Lifestyle

Intervention code [2]

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]

Change in body fat assessed using DEXA scan,

Timepoint [1]

1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement

Primary outcome [2]

Change in body weight assessed using a weight scale

Timepoint [2]

1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement

Secondary outcome [1]

Change in depression levels assessed using SCID-5

Timepoint [1]

1-Baseline
2- Four weeks after intervention commencement
3- Eight weeks after intervention commencement
4- Twelve weeks weeks after intervention commencement

Secondary outcome [2]

Change in C-reactive protein levels assessed using blood samples

Timepoint [2]

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?

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]

3086 - La Trobe University

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University

Ethics committee address [1]

Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2017

Approval date [1]

11/10/2019

Ethics approval number [1]

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

Dr Chandana Deekshith

Address

PhD Student at the the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Country

Australia

Phone

+613 9479 5755

Fax

20526448@students.latrobe.edu.au

Contact person for public queries

Name

Jency Thomas

Address

Lecturer in the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Country

Australia

Phone

+613 9479 5755

Fax

j.thomas@latrobe.edu.au

Contact person for scientific queries

Name

Mark Jois

Address

Senior Lecturer in the College of Science, Health and Engineering School
At Latrobe University
Address: Plenty Road & Kingsbury Drive, Melbourne VIC 3086

Country

Australia

Phone

+613 9479 2172

Fax

M.Jois@latrobe.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7085	Ethical approval			20526448@students.latrobe.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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