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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

NCT00997256

Healthy Sleep Quality

COMPLETED PHASE1

Effects of Valerian on Sleep in Healthy Older Adults

NCT00097604

Sleep Initiation and Maintenance Disorders

COMPLETED PHASE2

Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints

NCT05194618

Sleep

COMPLETED PHASE2/PHASE3

Feasibility Study on the Use of Redormin®500 on Day-time Cognition

NCT05684523

Sleep Disorders, Circadian Rhythm Cognitive Dysfunction

COMPLETED PHASE4

Effects of Orally Administered Thymus Vulgaris Leaves on Memory, Anxiety, Depression, and Sleep Quality in University Students: A Randomized Controlled Trial

NCT05987228

Memory Dysfunction Anxiety Depression +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mood Modulation Modulation of Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

102mg extract 1 hops

Equivalent to 0.5g dry weight

Group Type ACTIVE_COMPARATOR

Hops Extract

Intervention Type DIETARY_SUPPLEMENT

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.

410mg extract 1 hops

Equivalent to 2g dry weight

Group Type ACTIVE_COMPARATOR

Hops Extract

Intervention Type DIETARY_SUPPLEMENT

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.

79mg extract 2 hops

Equivalent to 0.5g dry weight

Group Type ACTIVE_COMPARATOR

Hops Extract

Intervention Type DIETARY_SUPPLEMENT

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.

316mg extract 2 hops

Equivalent to 2g dry weight

Group Type ACTIVE_COMPARATOR

Hops Extract

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo (silica)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hops Extract

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo (silica)

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes