Malt-derived Ingredients and Their Prolactinotrophic Effects

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT04796259

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Response to Food Ingredient Consumption	Dietary Supplement: Malt ingredient Dietary Supplement: Non-alcoholic beer solids	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Malt-derived Ingredients and Their Prolactinotrophic Effects

Actual Study Start Date :

Feb 5, 2021

Actual Primary Completion Date :

May 7, 2021

Actual Study Completion Date :

May 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Société des produits Nestlé/Metabolic Unit	Lausanne		Switzerland	1000

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator: Jose M. Ramos Nieves, M.Sc.; Ph.D., Société des Produits Nestlé S.A./NIHS
Study Director: Pamela Sun, Société des Produits Nestlé S.A./CIL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT04796259

Other Study ID Numbers:

20.21.NRC

First Posted:

Mar 12, 2021

Last Update Posted:

Feb 8, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 8, 2022