Malt-derived Ingredients and Their Prolactinotrophic Effects
NCT ID: NCT04796259
Last Updated: 2022-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2021-02-05
2021-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Negative control
Water
No interventions assigned to this group
Positive control
Non-alcoholic beer solids
Non-alcoholic beer solids
Solution with non-alcoholic beer solids
Intervention 1
Malt ingredient I
Malt ingredient
Solution with malt-derived ingredient
Intervention 2
Malt ingredient II
Malt ingredient
Solution with malt-derived ingredient
Interventions
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Malt ingredient
Solution with malt-derived ingredient
Non-alcoholic beer solids
Solution with non-alcoholic beer solids
Eligibility Criteria
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Inclusion Criteria
1. Willing and able to provide written informed consent
2. Healthy women aged 18 to 40.
3. BMI in the range of 18 to 30.
4. Willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period.
Exclusion Criteria
* Allergic to tested products
* Under regular medication including oral contraceptive pills or other form of hormonal replacement therapy.
* Under medications which affects prolactin levels.
* Pregnant or lactating or planning to conceive during the study period.
* Smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse.
* Not willing and/or not able to comply with the study procedures and requirements.
* Suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study.
* Family or hierarchical relationships with research team members
18 Years
40 Years
FEMALE
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Jose M. Ramos Nieves, M.Sc.; Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Société des Produits Nestlé S.A./NIHS
Pamela Sun
Role: STUDY_DIRECTOR
Société des Produits Nestlé S.A./CIL
Locations
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Société des produits Nestlé/Metabolic Unit
Lausanne, , Switzerland
Countries
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Other Identifiers
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20.21.NRC
Identifier Type: -
Identifier Source: org_study_id
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