Malt-derived Ingredients and Their Prolactinotrophic Effects

February 7, 2022 updated by: Nestlé
This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1000
        • Société des produits Nestlé/Metabolic Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours post consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours post consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 5, 2021

Primary Completion (ACTUAL)

May 7, 2021

Study Completion (ACTUAL)

May 7, 2021

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20.21.NRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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