Status:
COMPLETED
Malt-derived Ingredients and Their Prolactinotrophic Effects
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Acute Response to Food Ingredient Consumption
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.
Eligibility Criteria
Inclusion
- Subjects who have/are
- Willing and able to provide written informed consent
- Healthy women aged 18 to 40.
- BMI in the range of 18 to 30.
- 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
- Subjects who have/are
- 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
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04796259
Start Date
February 5 2021
End Date
May 7 2021
Last Update
February 8 2022
Active Locations (1)
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1
Société des produits Nestlé/Metabolic Unit
Lausanne, Switzerland, 1000