NCT01376869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

6 months

First QC Date

June 16, 2011

Last Update Submit

June 22, 2012

Conditions

Mood ModulationModulation of Cognition

Keywords

HopsMoodCognitive FunctionBioavailabilitySatietyBlood PressureHeart rate

Outcome Measures

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.

    across 3 hours

Secondary Outcomes (3)

  • Satiety

    across 3 hours

  • Bioavailability of Hops

    across 3 hours

  • Cognition

    across 3 hours

Study Arms (5)

102mg extract 1 hops

ACTIVE COMPARATOR

Equivalent to 0.5g dry weight

Dietary Supplement: Hops Extract

410mg extract 1 hops

ACTIVE COMPARATOR

Equivalent to 2g dry weight

Dietary Supplement: Hops Extract

79mg extract 2 hops

ACTIVE COMPARATOR

Equivalent to 0.5g dry weight

Dietary Supplement: Hops Extract

316mg extract 2 hops

ACTIVE COMPARATOR

Equivalent to 2g dry weight

Dietary Supplement: Hops Extract

Placebo

PLACEBO COMPARATOR
Other: Placebo (silica)

Interventions

Hops ExtractDIETARY_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.

102mg extract 1 hops316mg extract 2 hops410mg extract 1 hops79mg extract 2 hops
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.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

ALPL protein, humanSilicon Dioxide

Intervention Hierarchy (Ancestors)

MineralsInorganic ChemicalsOxidesOxygen CompoundsSilicon Compounds

Study Officials

  • Crystal Haskell

    Northumbria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

GB(1)