Acute Response to Food Ingredient ConsumptionNCT04796259
Malt-derived Ingredients and Their Prolactinotrophic Effects
A study testing Malt ingredient and Non-alcoholic beer solids in people with Acute Response to Food Ingredient Consumption, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Response to Food Ingredient Consumption
- What is being tested?
- Malt ingredient and Non-alcoholic beer solids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2021to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Société des produits Nestlé/Metabolic Unit
Lausanne, 1000
About this study
This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.
- Being tested
- Malt ingredient, Non-alcoholic beer solids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malt ingredientDietary supplement
Solution with malt-derived ingredient
Non-alcoholic beer solidsDietary supplement
Solution with non-alcoholic beer solids
| Study group | Role | What they receive |
|---|---|---|
| Negative control | No intervention | Water |
| Positive control | Active comparator | Non-alcoholic beer solids Receives: Dietary Supplement: Non-alcoholic beer solids |
| Intervention 1 | Experimental | Malt ingredient I Receives: Dietary Supplement: Malt ingredient |
| Intervention 2 | Experimental | Malt ingredient II Receives: Dietary Supplement: Malt ingredient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolactinotrophic effect
Δ of serum Prolactin Cmax between test products, positive control of beer solids and negative control of still water
Measured: 2 hours post consumption
Secondary outcomes (1)
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.
Measured: 2 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start5 Feb 2021
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Response to Food Ingredient ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose M. Ramos Nieves, M.Sc.; Ph.D., Principal investigator, Société des Produits Nestlé S.A./NIHSPamela Sun, Study director, Société des Produits Nestlé S.A./CIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796259
- Sponsor's protocol ID
- 20.21.NRC
- Status last verified
- Feb 2022
- First submitted
- 11 Mar 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malt-derived Ingredients and Their Prolactinotrophic Effects
- ClinicalTrials.gov ID
- NCT04796259
- Acronym / sponsor ID
- 20.21.NRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Negative control | No intervention | –Water |
| Positive control | Active comparator | Dietary Supplement: Non-alcoholic beer solidsNon-alcoholic beer solids |
| Intervention 1 | Experimental | Dietary Supplement: Malt ingredientMalt ingredient I |
| Intervention 2 | Experimental | Dietary Supplement: Malt ingredientMalt ingredient II |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who have/are
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malt ingredientSolution with malt-derived ingredient | Dietary supplement | Intervention 1, Intervention 2 |
| Non-alcoholic beer solidsSolution with non-alcoholic beer solids | Dietary supplement | Positive control |
Primary outcome
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
1 secondary outcome
Gastrointestinal tolerability
Time frame: 2 hours post consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M. Ramos Nieves, M.Sc.; Ph.D. principal investigator
Société des Produits Nestlé S.A./NIHS
Pamela Sun study director
Société des Produits Nestlé S.A./CIL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malt ingredient and Non-alcoholic beer solids in people with Acute Response to Food Ingredient Consumption, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolactinotrophic effect (time frame: 2 hours post consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.