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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mood Modulation, Modulation of Cognition

Intervention / Treatment
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* Dietary Supplement: Hops Extract
* Other: Placebo (silica)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 102mg extract 1 hops<br>Equivalent to 0.5g dry weight | Dietary Supplement: Hops Extract<br>* 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.<br>|
| Active Comparator: 410mg extract 1 hops<br>Equivalent to 2g dry weight | Dietary Supplement: Hops Extract<br>* 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.<br>|
| Active Comparator: 79mg extract 2 hops<br>Equivalent to 0.5g dry weight | Dietary Supplement: Hops Extract<br>* 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.<br>|
| Active Comparator: 316mg extract 2 hops<br>Equivalent to 2g dry weight | Dietary Supplement: Hops Extract<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo (silica)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | across 3 hours | 
| Bioavailability of Hops | • Plasma hops levels are to be examined to assess bioavailability. | 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. | across 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hops, Mood, Cognitive Function, Bioavailability, Satiety, Blood Pressure, Heart rate