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Completed

NCT Number: NCT04796259

Malt-derived Ingredients and Their Prolactinotrophic Effects

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

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Key information

Conditions

Acute Response to Food Ingredient Consumption

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Société des produits Nestlé/Metabolic Unit

Lausanne, 1000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Malt ingredient

Dietary Supplement

Solution with malt-derived ingredient

Non-alcoholic beer solids

Dietary Supplement

Solution with non-alcoholic beer solids

Primary outcomes

  1. Prolactinotrophic effect

    Time frame: 2 hours post consumption

    Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water

Secondary outcomes

  1. Gastrointestinal tolerability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2021
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.