Mood ModulationNCT01376869
Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
A study testing Hops Extract in people with Mood Modulation and Modulation of Cognition, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Modulation, Modulation of Cognition
- What is being tested?
- Hops Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
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.
- Conditions
- Mood Modulation, Modulation of Cognition
- Being tested
- Hops Extract, Placebo (silica)
- Keywords
- Hops, Mood, Cognitive Function, Bioavailability, Satiety, Blood Pressure, Heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 102mg extract 1 hops | Active comparator | Equivalent to 0.5g dry weight Receives: Dietary Supplement: Hops Extract |
| 410mg extract 1 hops | Active comparator | Equivalent to 2g dry weight Receives: Dietary Supplement: Hops Extract |
| 79mg extract 2 hops | Active comparator | Equivalent to 0.5g dry weight Receives: Dietary Supplement: Hops Extract |
| 316mg extract 2 hops | Active comparator | Equivalent to 2g dry weight Receives: Dietary Supplement: Hops Extract |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (silica) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: across 3 hours
Secondary outcomes (3)
Satiety
- Satiety as assessed by VAS (hungry/full/desire to eat/food intake).
- The modulation of satiety (VAS) inculcated by completion of the cognitive tasks.
Measured: across 3 hours
Bioavailability of Hops
- Plasma hops levels are to be examined to assess bioavailability.
Measured: across 3 hours
Cognition
- 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.
Measured: across 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood ModulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Responsible party
- Principal investigator, Crystal Haskell, Northumbria University
- Investigators
- Crystal Haskell, Study director, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376869
- Sponsor's protocol ID
- 21AO1
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2011
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
- ClinicalTrials.gov ID
- NCT01376869
- Acronym / sponsor ID
- 21AO1
- Conditions
- Mood Modulation, Modulation of Cognition
- Keywords
- Hops, Mood, Cognitive Function, Bioavailability, Satiety, Blood Pressure, Heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 102mg extract 1 hops | Active comparator | Dietary Supplement: Hops ExtractEquivalent to 0.5g dry weight |
| 410mg extract 1 hops | Active comparator | Dietary Supplement: Hops ExtractEquivalent to 2g dry weight |
| 79mg extract 2 hops | Active comparator | Dietary Supplement: Hops ExtractEquivalent to 0.5g dry weight |
| 316mg extract 2 hops | Active comparator | Dietary Supplement: Hops ExtractEquivalent to 2g dry weight |
| Placebo | Placebo comparator | Other: Placebo (silica) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male/female,
- Healthy
- Age 18-35 years old
- Non smoker
- Proficient in English
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hops ExtractAll 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. | Dietary supplement | 102mg extract 1 hops, 316mg extract 2 hops, 410mg extract 1 hops, 79mg extract 2 hops |
| 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. | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Satiety
Time frame: across 3 hours
Bioavailability of Hops
Time frame: across 3 hours
Cognition
Time frame: across 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Haskell study director
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hops Extract in people with Mood Modulation and Modulation of Cognition, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood (time frame: across 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.