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Blood Glucose, LowEarly Phase 1NCT04991714

Effect of Sweetness Intensity of a Sucrose Solution on Blood Glucose Regulation and Energy Intake

A Early Phase 1 study testing Lactisole, Rebaudioside M and Sucrose in people with Blood Glucose, Low and Hunger, run by University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the present study is to investigate the influence of the modulation of the sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in particular the regulation of blood glucose concentration and regulation of hunger \& satiety. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Blood Glucose, Low, Hunger
What is being tested?
Lactisole, Rebaudioside M and Sucrose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteAustria
Study dates
5 Aug 2021to 30 Dec 2022
Phase
Early Phase 1
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • male
  • healthy
  • non-smoking
  • normal taste responses towards sweet taste

Who cannot join

  • female
  • regular smokers
  • disturbed glucose and/or lipid metabolism
  • regular intake of medication
  • known allergies against one of the test compounds
  • ageusia
  • alcohol or drug addiction
  • intake of antibiotics within the past 2 months

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Christian Doppler Laboratory for Taste Research

    Vienna, 1090

Other trials in Austria

About this study

Official title: Einfluss Der Süßintensität Einer Saccharose-Lösung Auf Die Blutglukoseregulation Und Energieaufnahme in Gesunden Männern

The aim of the present study is to investigate the influence of the modulation of the sweetness intensity of a carbohydrate (sucrose)-containing solution on metabolic effects, in particular the regulation of blood glucose concentration and regulation of hunger \& satiety.

Read the detailed description

The study is designed as a randomised cross-over intervention study with four interventions. The study investigates the influence of sweetness modulation by Rebaudioside M (sweetness enhancement) and Lactisol (sweetness inhibition) of a 10% sucrose solution, corresponding to the concentration of a regular soft drink, on blood glucose regulation (blood glucose concentration and regulating hormones) in healthy male volunteers. Furthermore, the study assesses ad libitum energy intake, individual feelings of hunger and satiety, metabolic responses to the interventions, and preference for sweet-tasting foods such as sugar and sweeteners. In addition, the participants' individual thresholds for sweet taste, as well as morphological markers for taste sensitivity and body composition will be recorded as potential influencing factors.

Being tested
Lactisole, Rebaudioside M, Sucrose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LactisoleDrug

    Also called 2-(4-methoxyphenoxy)propionic acid, CAS Number: 150436-68-3

    sweet taste inhibitor (decreases sweetness)

  • Rebaudioside MDrug

    Also called CAS Number: 1220616-44-3

    Sweetener (increases sweetness)

  • SucroseOther

    Also called table sugar

    10% Sucrose corresponding to a regular soft drink

Study groups in NCT04991714
Study groupRoleWhat they receive
SucroseExperimental10% solution in water
Receives: Other: Sucrose
Sucrose + Reb MExperimental10% sucrose + 60 mg/L Rebaudioside M
Receives: Drug: Rebaudioside M; Other: Sucrose
Sucrose + LactisoleExperimental10% sucrose + 30 mg/ L Lactisole
Receives: Drug: Lactisole; Other: Sucrose
Sucrose + Reb M + LactisoleExperimental10% sucrose + 60 mg/L Rebaudioside M + 30 mg/ L Lactisole
Receives: Drug: Lactisole; Drug: Rebaudioside M; Other: Sucrose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood glucose concentration

    Glucose concentration [mg/dL] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

    Measured: over a time span of 120 minutes after drinking the test solution

  2. Insulin concentration

    Insulin concentration [mmol/L] in plasma samples before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

    Measured: over a time span of 120 minutes after drinking the test solution

  3. GLP-1 concentration

    Glucagon-like peptide 1 concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

    Measured: over a time span of 120 minutes after drinking the test solution

  4. GIP-concentration

    Gastric inhibitory polypeptide concentration in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

    Measured: over a time span of 120 minutes after drinking the test solution

Secondary outcomes (2)

  1. Food intake

    Ad libitum Food intake from a standardized breakfast

    Measured: 120 minutes after drinking of the test solution

  2. Metabolic changes

    Metabolome analysis in plasma samples [mmol/L] before, and 15, 30, 60, 90, and 120 minutes after drinking the test solution

    Measured: over a time span of 120 minutes after drinking the test solution

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start5 Aug 2021
  3. Primary completion15 Dec 2021
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991714
Sponsor's protocol ID
706014-1
Status last verified
Jan 2023
First submitted
19 Jul 2021
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Lactisole, Rebaudioside M and Sucrose in people with Blood Glucose, Low and Hunger, run by University of Vienna at 1 site in Austria.

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 4 inclusion and 8 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 26 Jan 2023. 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 Austria. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Blood glucose concentration (time frame: over a time span of 120 minutes after drinking the test solution). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04991714.

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 26 Jan 2023.

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