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

Tracking Information
First Submitted Date  ICMJE June 16, 2011
First Posted Date  ICMJE June 20, 2011
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
  • 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.
  • Bioavailability of Hops [ Time Frame: across 3 hours ]
    • Plasma hops levels are to be examined to assess bioavailability.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Official Title  ICMJE Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Mood Modulation
  • Modulation of Cognition
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 102mg extract 1 hops
    Equivalent to 0.5g dry weight
    Intervention: Dietary Supplement: Hops Extract
  • Active Comparator: 410mg extract 1 hops
    Equivalent to 2g dry weight
    Intervention: Dietary Supplement: Hops Extract
  • Active Comparator: 79mg extract 2 hops
    Equivalent to 0.5g dry weight
    Intervention: Dietary Supplement: Hops Extract
  • Active Comparator: 316mg extract 2 hops
    Equivalent to 2g dry weight
    Intervention: Dietary Supplement: Hops Extract
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo (silica)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 16, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01376869
Other Study ID Numbers  ICMJE 21AO1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crystal Haskell, Northumbria University
Study Sponsor  ICMJE Northumbria University
Collaborators  ICMJE The New Zealand Institute for Plant and Food Research
Investigators  ICMJE
Study Director: Crystal Haskell Northumbria University
PRS Account Northumbria University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP