The study will involve approximately 100 adults aged over 18 years, who will each participate for a period of 8 weeks.

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis which means that your individual start date is flexible. Your involvement in this study will be 8 weeks.

The investigational product is a commercially available capsule-form extract of Caralluma fimbriata plant (Caralluma). Previous research has shown the product to have beneficial effects on reducing anxiety at a 1g per day dose. All clinical studies, to date, found the product to be safe for use with no serious adverse effects associated with its oral administration. This study aims to investigate the efficacy of this Caralluma extract in improving symptoms of stress such as poor sleep, agitation, feeling overwhelmed or constant worrying.

The natural herbal extract will be taken as a 500 mg total daily dose in capsule form (2 capsules per day).

As this study is placebo-controlled, you may or may not be allocated the active product. 50% of participants will be assigned the placebo (a harmless inactive substance typically used as an additive in food production). During the study period, neither you nor the study investigators will know which product you have been allocated.

The aim of this study is to assess the effectiveness of Caralluma fimbriata on stress, sleep and neurotransmitters in a healthy adult population over an 8 week period.

In the United States, anxiety disorders affect an estimated one in eight women and one in ten men, thus highlighting anxiety as the most prevalent mental health condition in the country.

These figures only increase when they include people who experience subclinical anxiety but have not been diagnosed with a disorder. There is a growing understanding that stress and subclinical anxiety also reduce quality of life, and contribute to physical illness such as high blood pressure and cardiovascular disease.

Pharmaceutical treatments for anxiety come with the risk of adverse effects such as diarrhea and nausea, habituation, dependency and withdrawal, and have low efficacy for subclinical presentations. Therefore, the need for alternatives, specifically for sub-clinical anxiety and stress has grown.

Caralluma is a succulent plant that grows from India to North Africa. Results of a human clinical study on 1g of extract daily indicated a significant reduction in anxiety.

This current study has been designed to further assess the effects of Caralluma fimbriata extract on stress (sub-clinical anxiety) at a lower dose (500mg). It will also measure the effect on sleep and explore the mechanism of action by testing neurotransmitters.

Your involvement in the study will be 8 weeks. During this time, you will be required to take the study product each day (2 capsules a day), and complete certain assessments at the beginning, middle and end of the study so that we can assess the effectiveness of the study product.

• Aged over 18 years
• Experiencing feelings of mild to moderate stress (such as poor sleep, agitation, feeling overwhelmed or constant worrying).
• Not currently receiving treatment for anxiety (eg. medication, counselling)
• Generally healthy with no uncontrolled serious illnesses
• A non-smoker
• Not suffering from any unstable or serious illness
• Willing to keep your diet and exercise routine the same whilst on the study
• Able to commit to the study for the 8-week period and attend 3 clinic visits during that time