HealthyNCT03613935
Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
A study testing Product 1, Product 2 and Product 3 in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Product 1, Product 2 and Product 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Feb 2018to 20 Apr 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18.5 and 29.9 kg/m2
- Fasting capillary blood glucose level ≤ 7 mmol/L
- Able to understand and sign an informed consent form
Who cannot join
- Pregnancy on anamnesis
- Lactating mothers
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
- Family history of type 2 diabetes (parents)
- Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor)
Show all 10Show fewer
- Known ageusia or other tasting trouble
- Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics)
- Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor
- Major medical/surgical event requiring hospitalisation in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.
In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.
Read the detailed description
After enrollment, participants will be asked to come to the investigational site 6 times for:
- two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
- 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.
- Conditions
- Healthy
- Being tested
- Product 1, Product 2, Product 3, Product 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product 1Other
Comparison with products 2, 3, and 4
Product 2Other
Comparison with products 1, 3, and 4
Product 3Other
Comparison with products 1, 2, and 4
Product 4Other
Comparison with products 1, 2, and 3
| Study group | Role | What they receive |
|---|---|---|
| Product 1 | Placebo comparator | Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered Receives: Other: Product 2; Other: Product 3; Other: Product 4 |
| Product 2 | Active comparator | Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered Receives: Other: Product 1; Other: Product 3; Other: Product 4 |
| Product 3 | Active comparator | Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered Receives: Other: Product 1; Other: Product 2; Other: Product 4 |
| Product 4 | Active comparator | Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered Receives: Other: Product 1; Other: Product 2; Other: Product 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area under the Curve (iAUC) of plasma glucose
Area under the curve
Measured: 0 to 3 hours post product intake
Secondary outcomes (6)
Incremental Area under the Curve (iAUC) of plasma insulin
Area under the curve
Measured: 0 to 3 hours post product intake
Cmax of plasma glucose
Maximal concentration of plasma glucose
Measured: between 0 and 3 hours post product intake
Cmax of plasma insulin
Maximal concentration of plasma insulin
Measured: between 0 and 3 hours post product intake
Tmax of plasma glucose
Time (min) for maximal concentration of plasma glucose
Measured: between 0 and 3 hours post product intake
Tmax of plasma insulin
Time (min) for maximal concentration of plasma insulin
Measured: between 0 and 3 hours post product intake
Sensory tasting capacity
Assessment of the sweetness of two beverages versus control through a questionnaire
Measured: immediately after product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start19 Feb 2018
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a monocentric, controlled, randomized, open, complete crossover study design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613935
- Sponsor's protocol ID
- 17.19.BIO
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
- ClinicalTrials.gov ID
- NCT03613935
- Acronym / sponsor ID
- 17.19.BIO
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 3 Aug 2018 (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.
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.
In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.
Detailed description
After enrollment, participants will be asked to come to the investigational site 6 times for:
- two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
- 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a monocentric, controlled, randomized, open, complete crossover study design
| Arm | Type | Receives |
|---|---|---|
| Product 1 | Placebo comparator | Other: Product 2, Other: Product 3, Other: Product 4Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered |
| Product 2 | Active comparator | Other: Product 1, Other: Product 3, Other: Product 4Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered |
| Product 3 | Active comparator | Other: Product 1, Other: Product 2, Other: Product 4Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered |
| Product 4 | Active comparator | Other: Product 1, Other: Product 2, Other: Product 3Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 18.5 and 29.9 kg/m2
- Fasting capillary blood glucose level ≤ 7 mmol/L
- Able to understand and sign an informed consent form
Key exclusion criteria (10 listed)
- Pregnancy on anamnesis
- Lactating mothers
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
- Family history of type 2 diabetes (parents)
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 |
|---|---|---|
| Product 1Comparison with products 2, 3, and 4 | Other | Product 2, Product 3, Product 4 |
| Product 2Comparison with products 1, 3, and 4 | Other | Product 1, Product 3, Product 4 |
| Product 3Comparison with products 1, 2, and 4 | Other | Product 1, Product 2, Product 4 |
| Product 4Comparison with products 1, 2, and 3 | Other | Product 1, Product 2, Product 3 |
Primary outcome
Incremental Area under the Curve (iAUC) of plasma glucose
Time frame: 0 to 3 hours post product intake
Area under the curve
6 secondary outcomes
Incremental Area under the Curve (iAUC) of plasma insulin
Time frame: 0 to 3 hours post product intake
Cmax of plasma glucose
Time frame: between 0 and 3 hours post product intake
Cmax of plasma insulin
Time frame: between 0 and 3 hours post product intake
Tmax of plasma glucose
Time frame: between 0 and 3 hours post product intake
Tmax of plasma insulin
Time frame: between 0 and 3 hours post product intake
Sensory tasting capacity
Time frame: immediately after product intake
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 3 Aug 2018.
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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.
Maurice Beaumont, MD principal investigator
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product 1, Product 2 and Product 3 in people with Healthy, 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 3 inclusion and 10 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 3 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Incremental Area under the Curve (iAUC) of plasma glucose (time frame: 0 to 3 hours post product intake). 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 3 Aug 2018.