Malt-derived Ingredients and Their Prolactinotrophic Effects

Acute Response to Food Ingredient Consumption Clinical Trial

Official title:

Malt-derived Ingredients and Their Prolactinotrophic Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796259
• Other study ID #: 20.21.NRC
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: May 7, 2021

Study information

• Verified date: February 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Response to Food Ingredient Consumption

Intervention

Dietary Supplement:
• Malt ingredient
Solution with malt-derived ingredient
• Non-alcoholic beer solids
Solution with non-alcoholic beer solids

Locations

Country	Name	City	State
Switzerland	Société des produits Nestlé/Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolactinotrophic effect	? of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water	2 hours post consumption
Secondary	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