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

This study has been completed.
Sponsor:
Collaborator:
The New Zealand Institute for Plant and Food Research
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University
ClinicalTrials.gov Identifier:
NCT01376869
First received: June 16, 2011
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Mood Modulation
Modulation of Cognition
Dietary Supplement: Hops Extract
Other: Placebo (silica)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Mood [ Time Frame: across 3 hours ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • Satiety [ Time Frame: across 3 hours ] [ Designated as safety issue: No ]
    • Satiety as assessed by VAS (hungry/full/desire to eat/food intake).
    • The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.

  • Bioavailability of Hops [ Time Frame: across 3 hours ] [ Designated as safety issue: No ]
    • Plasma hops levels are to be examined to assess bioavailability.

  • Cognition [ Time Frame: across 3 hours ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 150
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 102mg extract 1 hops
Equivalent to 0.5g dry weight
Dietary Supplement: 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.
Active Comparator: 410mg extract 1 hops
Equivalent to 2g dry weight
Dietary Supplement: 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.
Active Comparator: 79mg extract 2 hops
Equivalent to 0.5g dry weight
Dietary Supplement: 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.
Active Comparator: 316mg extract 2 hops
Equivalent to 2g dry weight
Dietary Supplement: 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.
Placebo Comparator: Placebo Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376869

Locations
United Kingdom
Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
The New Zealand Institute for Plant and Food Research
Investigators
Study Director: Crystal Haskell Northumbria University
  More Information

No publications provided

Responsible Party: Crystal Haskell, Research Fellow, Northumbria University
ClinicalTrials.gov Identifier: NCT01376869     History of Changes
Other Study ID Numbers: 21AO1
Study First Received: June 16, 2011
Last Updated: June 22, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
Hops
Mood
Cognitive Function
Bioavailability
Satiety
Blood Pressure
Heart rate

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014