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Completed

NCT Number: NCT01376869

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

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.

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Key information

Conditions

Mood Modulation Modulation of Cognition

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hops Extract

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 (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.

Primary outcomes

  1. Mood

    Time frame: across 3 hours

    • 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.

Secondary outcomes

  1. Satiety

    Time frame: across 3 hours

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

  2. Bioavailability of Hops

    Time frame: across 3 hours

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

  3. Cognition

    Time frame: across 3 hours

    • 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.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • The New Zealand Institute of Plant and Food Research Ltd.

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.