Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
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ClinicalTrials.gov Identifier: NCT01376869 |
Recruitment Status :
Completed
First Posted : June 20, 2011
Last Update Posted : June 25, 2012
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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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 102mg extract 1 hops
Equivalent to 0.5g dry weight
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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. |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United Kingdom | |
Northumbria University | |
Newcastle upon Tyne, United Kingdom, NE1 8ST |
Study Director: | Crystal Haskell | Northumbria University |
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 |
Hops Mood Cognitive Function Bioavailability |
Satiety Blood Pressure Heart rate |