Acute Response to Food Ingredient Consumption
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMalt ingredient
Solution with malt-derived ingredient
DIETARY_SUPPLEMENTNon-alcoholic beer solids
Solution with non-alcoholic beer solids
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who have/are 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolactinotrophic effect | 2 hours post consumption | Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerability | 2 hours post consumption | • Gastro-intestinal tolerability assessment with a visual analogue scale for each symptom of interest i.e.1) Abdominal discomfort 2) Nausea 3) Vomiting 4) Diarrhoea 5) ↓appetite. |
Countries
Switzerland
Outcome results
None listed