Malt-derived Ingredients and Their Prolactinotrophic Effects

Nestlé

Status: Completed

Conditions: Acute Response to Food Ingredient Consumption

Treatments: Dietary Supplement: Malt ingredient; Dietary Supplement: Non-alcoholic beer solids

Study type: Interventional

Funder types: Industry

Identifiers

NCT04796259

20.21.NRC

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Negative control

No Intervention group

Description:

Water

Positive control

Active Comparator group

Description:

Non-alcoholic beer solids

Treatment:

Dietary Supplement: Non-alcoholic beer solids

Intervention 1

Experimental group

Description:

Malt ingredient I

Treatment:

Dietary Supplement: Malt ingredient

Intervention 2

Experimental group

Description:

Malt ingredient II

Treatment:

Dietary Supplement: Malt ingredient