Malt-derived Ingredients and Their Prolactinotrophic Effects

Study Overview
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Brief Summary
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This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.

Official Title
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Malt-derived Ingredients and Their Prolactinotrophic Effects

Conditions
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Acute Response to Food Ingredient Consumption

Intervention / Treatment
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* Dietary Supplement: Malt ingredient
* Dietary Supplement: Non-alcoholic beer solids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Negative control<br>Water | |
| Active Comparator: Positive control<br>Non-alcoholic beer solids | Dietary Supplement: Non-alcoholic beer solids<br>* Solution with non-alcoholic beer solids<br>|
| Experimental: Intervention 1<br>Malt ingredient I | Dietary Supplement: Malt ingredient<br>* Solution with malt-derived ingredient<br>|
| Experimental: Intervention 2<br>Malt ingredient II | Dietary Supplement: Malt ingredient<br>* Solution with malt-derived ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolactinotrophic effect | Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water | 2 hours post consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerability | • 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. | 2 hours post consumption |