None listed
Conditions
Brief summary
The underlying principle of trials evaluating the effectiveness of pharmacological treatments is to compare a drug against a placebo. The difference in effectiveness is then attributed to the active ingredient of the drug. Typically, placebos are designed to resemble the drug as much as possible, but conventional placebos that only contain lactose fibres do not elicit side effects and therefore do not fully resemble all features of the drug. The primary aim of this study is to evaluate if side effects increase the effectiveness of an otherwise inactive placebo treatment. We therefore developed an active placebo that will elicit side effects, but otherwise has no effect on sleep. We hypothesise that active placebos eliciting side effects demonstrate a larger placebo effect for sleep compared with conventional placebos that only contain lactose fibres.
Interventions
Participants will be recruited under the guise of a study testing a new formulation of an antihistaminic drug containing beetroot extract as an antioxidant efficacy booster, but no active treatment is actually delivered. Instead, after one week of baseline measures participants will be randomised to one of three groups: a conventional benign placebo group, an active placebo group, or to a no-treatment control group. Participants randomised to the benign and active placebo groups will be led to believe they are receiving the antihistaminic drug. The no-treatment control group will be told that they will not receive treatment and will instead serve as a control group for the natural course of their sleep difficulty and daily symptoms. The placebo capsules will be made of gelatine. The benign placebo group will receive four conventional placebo capsules per day for 7 days containing only lactose fibres as filler material. The active placebo group will receive four capsules per day for 7 days containing each 500 mg of the food colour E 162, i.e. beetroot extract and 250 mg oxalic acid to stabilise and guarantee the absorption of the beetroot extract. The intention of the active placebo is to produce beeturia, i.e. a red-ish colouration of the urine to simulate side effects. Adherence will be assessed using a daily participant diary. Additionally, participants will need to return the capsule container containing all capsules they haven't taken at the end of the study.
Sponsors
Study design
Eligibility
Inclusion criteria
(1) at least 18 years of age
Exclusion criteria
(1) taking prescription medication (other than the contraceptive pills); (2) pregnancy, trying to conceive, or breastfeeding; (3) received treatment for sleep difficulty in the last three months; (4) antihistamine, beetroot, or lactose allergy, or any other intolerances; (5) abnormal/deficient kidney functioning or any other medical condition