Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants

Northumbria University

Status: Completed

Conditions: Modulation of Cognition; Mood Modulation

Treatments: Other: Placebo (silica); Dietary Supplement: Hops Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01376869

21AO1

Details and patient eligibility

About

Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.

However, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.

The current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male/female,
• Healthy
• Age 18-35 years old
• Non smoker
• Proficient in English
• Not taking any herbal or prescription medications
• Not pregnant seeking to become pregnant or breastfeeding

Exclusion criteria

• Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.
• Vegetarian (as the capsules contain gelatine).
• Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).
• Have a current/ history of drug or alcohol abuse.
• Currently take medication (excluding the contraceptive pill).
• High Blood Pressure (>140/90)
• BMI outside of the range 18- 34.9

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 5 patient groups, including a placebo group

102mg extract 1 hops

Active Comparator group

Description:

Equivalent to 0.5g dry weight

Treatment:

Dietary Supplement: Hops Extract

410mg extract 1 hops

Active Comparator group

Description:

Equivalent to 2g dry weight

Treatment:

Dietary Supplement: Hops Extract

79mg extract 2 hops

Active Comparator group

Description:

Equivalent to 0.5g dry weight

Treatment:

Dietary Supplement: Hops Extract

316mg extract 2 hops

Active Comparator group

Description:

Equivalent to 2g dry weight

Treatment:

Dietary Supplement: Hops Extract

Placebo

Placebo Comparator group

Treatment:

Other: Placebo (silica)