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

Northumbria University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

150

Conditions

Mood Modulation Modulation of Cognition

Interventions

All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.

Placebo (silica)OTHER

All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers were used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mood

* Mood as assessed by STAI, Bond-Lader mood scales, POMS, DEQ and stress/euphoria/sedation visual analogue scales (VAS). * The shift in mood (STAI, Bond-Lader, POMS, DEQ, Stress/Euphoria/Sedation VAS) inculcated by completion of cognitive tasks. * Heart rate and blood pressure. * The modulation of blood pressure and heart rate inculcated by completion of cognitive tasks.

Time frame: across 3 hours

Secondary Outcomes

Satiety

* Satiety as assessed by VAS (hungry/full/desire to eat/food intake). * The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.

Time frame: across 3 hours

Bioavailability of Hops

• Plasma hops levels are to be examined to assess bioavailability.

Time frame: across 3 hours

Cognition

* Performance on working memory tasks (2-back and logical reasoning). * Performance on serial subtraction element of a dual task. * Performance on word and picture recognition tasks.

Time frame: across 3 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes