None listed
Conditions
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).
Interventions
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 o
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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 54 Years
Healthy volunteers
No
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
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.
Outcome results
None listed