Assessing anti-stress effects of lemon balm-containing foods

Assessing the anti-stress effects of lemon balm-containing foods in healthy participants

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000864224

Enrollment

Registered

2009-10-06

Start date

2008-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objectives of the current study is to conduct three studies to assess the effects of single doses of Melissa officinalis (Lemon balm), delivered in different food and drink products, on cognitive function, mood and cortisol. The products will vary across the three studies and will include Beverages (Study 1), Dairy products (Study 2), and food Bars (Study 3). This will be a randomised, double-blind, placebo-controlled, crossover study design involving a cohort of 20 healthy young adult volunteers in each study. On each study day participants will undergo a baseline (pre-treatment) assessment of cognitive performance, mood and cortisol reactivity. They will undergo similar assessment 1 hour and 3 hours after treatment administration. The procedure will be repeated at weekly intervals until all doses are complete. Each study will allow comprehensive conclusions regarding dose-dependent effects of Lemon balm (delivered in different foods) on: - Mood including: Alertness, Calmness, Contentment - Cognitive function including: Attention, Working memory, Secondary memory, and Executive function. - Physiological index of stress: Salivary cortisol

Interventions

Study 1: Beverages Study 1 will compare the effects of 480ml drinks containing -1.8 g Lemon balm + Natural sweetener -1 g Lemon balm + Natural sweetener -1.8 g Lemon balm + artificial sweetener -a placebo that containing artificial sweetener Study 2. Dairy products Study 2 will compare the effects of 250g dairy products (yoghurt drink) containing - 1.8 g Lemon balm + Natural sweetener - 1 g Lemon balm + Natural sweetener - 1.8 g Lemon balm + artificial sweetener - a placebo containing an artificial sweetener Study 3. Bars Study 3 will compare the effects of 35g fruit bars containing - 1.8 g Lemon balm + Natural sweetener - 1.8g Lemon balm + artificial sweetener - Natural sweetener - Artificial sweetener For each study, participants consumed each treatment once only. There was a minimum 7 day washout period between each treatment within each study. Participants were recruited for 1 study at a time. Therefore, it is possible that the same participants may respond to the advertisement of more than 1 study.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

- non smoker - aged between 18 and 40 years - no history of anxiety, depression or psychiatric disorders - not taking any medication, herbal extracts, vitamin supplements or illicit drugs - no health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, celiac disease, peptic ulcers) - not pregnant or breast feeding.

Exclusion criteria

- smoker - history of anxiety, depression or psychiatric disorders - taking any medication, herbal extracts, vitamin supplements or illicit drugs - health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, peptic ulcers) - pregnant or breast feeding.

Outcome results