CClinicalTrials.gg
CompletedNCT01376869Updated Jun 25, 2012

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

An interventional study of Hops Extract and Placebo (silica) in Mood Modulation and Modulation of Cognition, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-25.

Sponsored by Northumbria University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Mood Modulation
  • Modulation of Cognition

Keywords

  • Hops
  • Mood
  • Cognitive Function
  • Bioavailability
  • Satiety
  • Blood Pressure
  • Heart rate
03

In context

Lead sponsor

Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    102mg extract 1 hops

    Equivalent to 0.5g dry weight

    Dietary Supplement: Hops Extract

  • Active comparator
    410mg extract 1 hops

    Equivalent to 2g dry weight

    Dietary Supplement: Hops Extract

  • Active comparator
    79mg extract 2 hops

    Equivalent to 0.5g dry weight

    Dietary Supplement: Hops Extract

  • Active comparator
    316mg extract 2 hops

    Equivalent to 2g dry weight

    Dietary Supplement: Hops Extract

  • Placebo comparator
    Placebo

    Other: Placebo (silica)

Interventions

  • Dietary supplementHops 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.

  • OtherPlacebo (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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Bioavailability of Hops

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

    Time frame: across 3 hours

  3. 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

07

Study locations

1 site
  • Northumbria University
    Newcastle upon Tyne, NE1 8ST, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01376869
Lead sponsor
Northumbria University
Collaborators
The New Zealand Institute for Plant and Food Research
Responsible party
Crystal Haskell (Research Fellow, Northumbria University) — Principal investigator
First posted
Jun 20, 2011
Start date
Jun 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jun 25, 2012

Study contacts

Crystal Haskell
study director · Northumbria University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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