Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01376869
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
The New Zealand Institute for Plant and Food Research
Information provided by (Responsible Party):
Crystal Haskell, Northumbria University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Mood Modulation Modulation of Cognition Dietary Supplement: Hops Extract Other: Placebo (silica) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376869


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Crystal Haskell Northumbria University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Crystal Haskell, Research Fellow, Northumbria University
ClinicalTrials.gov Identifier: NCT01376869    
Other Study ID Numbers: 21AO1
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012
Keywords provided by Crystal Haskell, Northumbria University:
Hops
Mood
Cognitive Function
Bioavailability
 Satiety
Blood Pressure
Heart rate