Postprandial Glucose ResponseNCT05266690
Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response
A study testing Roquette Glucidex 2, Pharmacosmos Dextran 10 and Roquette Glucidex 40 in people with Postprandial Glucose Response, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The primary research project objective is to investigate whether a maltodextrin with high degree of polymerization (Roquette Glucidex 2) and a dextran with comparable degree of polymerization (Pharmacosmos Dextran 10) have lower post-prandial glucose response than glucose syrup (Roquette Glucidex 40). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose Response
- What is being tested?
- Roquette Glucidex 2, Pharmacosmos Dextran 10 and Roquette Glucidex 40
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Nov 2019to 18 Feb 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participant
- Healthy status (based on anamnesis)
- Age between 18 and 45 years
- BMI between 18.5 and 29.9 kg/m2
- Able to understand and sign an informed consent form
- Able to respect the study procedures and timelines
- Swiss resident living in canton Fribourg (French part), Neuchâtel, Vaud and Valais which is in the competence of Ethical Committee of Vaud
- Having wireless internet access at home
Who cannot join
- Any known metabolic disease including diabetes or drug chronic intake (aspirin, vitamin C and mineral supplements, steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics…) possibly impacting (to the opinion of the medical responsible): The digestion or absorption of nutrients, the postprandial glucose response
- Major medical/surgical event requiring hospitalization in the last 3 months
- Pregnancy or lactation
- Known food allergy and intolerance
- Medically known cutaneous hypersensitivity to adhesives, silicon watch-strap and plasters
- 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.
- Smokers
- Participant having a hierarchical link with the research team members
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestlé Research - Clinical Research Unit - Clinical Innovation Lab
Lausanne, Canton of Vaud, 1000
About this study
The primary research project objective is to investigate whether a maltodextrin with high degree of polymerization (Roquette Glucidex 2) and a dextran with comparable degree of polymerization (Pharmacosmos Dextran 10) have lower post-prandial glucose response than glucose syrup (Roquette Glucidex 40). To confer further robustness to the results, the post-prandial glucose response will be compared to a negative control represented by a resistant dextrin with a complex structure containing 70% non-digestible dietary fiber (Promitor 70), which is currently used for sugar replacement.
Additional key objective is to investigate the safety and gastrointestinal tolerability of the investigational products.
Read the detailed description
The aim of the present research project is to generate comparative data on post-prandial glucose response (PPGR) of α-glucans varying systematically degree of polymerization and linkage type. These data are expected to contribute to the sugar replacement strategy in food industry.
An additional goal of the study is to demonstrate the feasibility of running a PPGR study remotely, i.e. with the participants carrying out most of the procedures at home.
Remote clinical trials (so called "virtual") have recently started to be implemented in pharmaceutical clinical research with the intent to reduce the burden on participants and investigational sites, narrow gaps with real life conditions, expand recruitment potential and maximize data collection. Nutritional research could be an even more suitable context for the remote approach because of the much lower safety risks for the participants.
However, with this innovative approach come new risks (at distance communication with the participants, complex data flows and logistics, lower degree of control on clinical trial execution) that can potentially affect the reliability of the study results and therefore require proper mitigation.
In the present study the following measures were put in place to reduce those risks:
- Clear and complete instructions will be provided to the subjects on how the carry out remotely the study procedures.
- Digital tools and devices used for data capture will be easy to use and the needed software will be pre-installed on a provided tablet.
- An electronic questionnaire will be used to induce subjects to follow the study procedures and to assess compliance afterwards.
- The heart rate and physical activity tracker will help determining if the subjects have followed the recommendation to avoid intense exercise in concomitance with the PPGR measurement
- A certain time flexibility is allowed to accommodate the participants' needs and reduce the risk of drop-outs.
- A conservative approach was used in the calculation of the sample size to reduce the risk of the study being underpowered in case of unexpected drop-out rate.
- The Metabolic Unit staff will be reachable, during working hours, by the participants to provide technical support and to monitor their safety.
- The study staff will be alerted via email every time that an adverse event is imputed in the adverse event collection tool.
The two products selected as positive and negative control for the present research project. Comparison of PPGR data generated in the present research project with existing data will allow evaluating the reliability of the remote approach compared to the traditional one.
- Conditions
- Postprandial Glucose Response
- Being tested
- Roquette Glucidex 2, Pharmacosmos Dextran 10, Roquette Glucidex 40, Promitor 70
- Keywords
- Postprandial glucose response, α-glucans, Polymerization, Decentralized study design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roquette Glucidex 2Dietary supplement
Roquette Glucidex 2: Maltodextrins with high degree of polymerization
Pharmacosmos Dextran 10Dietary supplement
Pharmacosmos Dextran 10: Dextran with high degree of polymerization
Roquette Glucidex 40Dietary supplement
Also called Positive control
Roquette Glucidex 40: Glucose syrup
Promitor 70Dietary supplement
Also called Negative control
Promitor 70: Resistant Dextrin with a complex structure containing 70% non-digestible dietary fiber
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Roquette Glucidex 40 - Roquette Glucidex 2 - Pharmacosmos Dextran 10 - Promitor 70 Receives: Dietary Supplement: Roquette Glucidex 2; Dietary Supplement: Pharmacosmos Dextran 10; Dietary Supplement: Roquette Glucidex 40; Dietary Supplement: Promitor 70 |
| Sequence 2 | Experimental | Roquette Glucidex 2 - Promitor 70 - Roquette Glucidex 40 - Pharmacosmos Dextran 10 Receives: Dietary Supplement: Roquette Glucidex 2; Dietary Supplement: Pharmacosmos Dextran 10; Dietary Supplement: Roquette Glucidex 40; Dietary Supplement: Promitor 70 |
| Sequence 3 | Experimental | Promitor 70 - Pharmacosmos Dextran 10 - Roquette Glucidex 2 - Roquette Glucidex 40 Receives: Dietary Supplement: Roquette Glucidex 2; Dietary Supplement: Pharmacosmos Dextran 10; Dietary Supplement: Roquette Glucidex 40; Dietary Supplement: Promitor 70 |
| Sequence 4 | Experimental | Pharmacosmos Dextran 10 - Roquette Glucidex 40 - Promitor 70 - Roquette Glucidex 2 Receives: Dietary Supplement: Roquette Glucidex 2; Dietary Supplement: Pharmacosmos Dextran 10; Dietary Supplement: Roquette Glucidex 40; Dietary Supplement: Promitor 70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose
Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose in the interstitial subcutaneous fluid as measured by a continuous glucose monitoring (Flash Glucose Monitoring FGM) commercial device (Abbott Freestyle Libre), as absolute values or as relative value to the raise observed for a glucose syrup as positive control and a resistant dextrin containing a non-digestible fiber as negative control
Measured: From 0 (product intake) to 120 minutes
Secondary outcomes (6)
Maximum concentration (Cmax) of post-prandial glucose
Maximum concentration (Cmax) of post-prandial glucose in the interstitial subcutaneous fluid as measured by FGM device
Measured: From 0 (product intake) to 120 minutes
Time of Cmax (Tmax) of post-prandial glucose
Time of Cmax (Tmax) of post-prandial glucose in the interstitial subcutaneous fluid as measured by FGM device
Measured: From 0 (product intake) to 120 minutes
Adverse events
Incidence, type, severity and relation to the research product of possible adverse events experienced by the participants during the study
Measured: Through subject participation, up to 2 weeks
Gastro-intestinal tolerability
Gastro-intestinal tolerability as assessed by visual analogue scale for the following symptoms: 1) Abdominal discomfort, 2) Decreased appetite, 3) Gastric reflux, 4) Nausea, 5) Diarrhea, 6) Headache
Measured: Through subject participation, up to 2 weeks
Heart rate
Continuous heart rate measure (recorded by wearable activity tracker)
Measured: Through subject participation, up to 2 weeks
Physical activity
Continuous physical activity measure (recorded by wearable activity tracker)
Measured: Through subject participation, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start29 Nov 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial Glucose ResponseStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Model description
- Monocentric, controlled, randomized, double-blind, complete 4x4 cross-over clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Sun, MD, Principal investigator, Nestlé Research - Clinical Research Unit - Clinical Innovation Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266690
- Sponsor's protocol ID
- 19.10.NRC
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response
- ClinicalTrials.gov ID
- NCT05266690
- Acronym / sponsor ID
- 19.10.NRC
- Conditions
- Postprandial Glucose Response
- Keywords
- Postprandial glucose response, α-glucans, Polymerization, Decentralized study design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 4 Mar 2022 (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.
The primary research project objective is to investigate whether a maltodextrin with high degree of polymerization (Roquette Glucidex 2) and a dextran with comparable degree of polymerization (Pharmacosmos Dextran 10) have lower post-prandial glucose response than glucose syrup (Roquette Glucidex 40). To confer further robustness to the results, the post-prandial glucose response will be compared to a negative control represented by a resistant dextrin with a complex structure containing 70% non-digestible dietary fiber (Promitor 70), which is currently used for sugar replacement.
Additional key objective is to investigate the safety and gastrointestinal tolerability of the investigational products.
Detailed description
The aim of the present research project is to generate comparative data on post-prandial glucose response (PPGR) of α-glucans varying systematically degree of polymerization and linkage type. These data are expected to contribute to the sugar replacement strategy in food industry.
An additional goal of the study is to demonstrate the feasibility of running a PPGR study remotely, i.e. with the participants carrying out most of the procedures at home.
Remote clinical trials (so called "virtual") have recently started to be implemented in pharmaceutical clinical research with the intent to reduce the burden on participants and investigational sites, narrow gaps with real life conditions, expand recruitment potential and maximize data collection. Nutritional research could be an even more suitable context for the remote approach because of the much lower safety risks for the participants.
However, with this innovative approach come new risks (at distance communication with the participants, complex data flows and logistics, lower degree of control on clinical trial execution) that can potentially affect the reliability of the study results and therefore require proper mitigation.
In the present study the following measures were put in place to reduce those risks:
- Clear and complete instructions will be provided to the subjects on how the carry out remotely the study procedures.
- Digital tools and devices used for data capture will be easy to use and the needed software will be pre-installed on a provided tablet.
- An electronic questionnaire will be used to induce subjects to follow the study procedures and to assess compliance afterwards.
- The heart rate and physical activity tracker will help determining if the subjects have followed the recommendation to avoid intense exercise in concomitance with the PPGR measurement
- A certain time flexibility is allowed to accommodate the participants' needs and reduce the risk of drop-outs.
- A conservative approach was used in the calculation of the sample size to reduce the risk of the study being underpowered in case of unexpected drop-out rate.
- The Metabolic Unit staff will be reachable, during working hours, by the participants to provide technical support and to monitor their safety.
- The study staff will be alerted via email every time that an adverse event is imputed in the adverse event collection tool.
The two products selected as positive and negative control for the present research project. Comparison of PPGR data generated in the present research project with existing data will allow evaluating the reliability of the remote approach compared to the traditional one.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Monocentric, controlled, randomized, double-blind, complete 4x4 cross-over clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Dietary Supplement: Roquette Glucidex 2, Dietary Supplement: Pharmacosmos Dextran 10, Dietary Supplement: Roquette Glucidex 40, Dietary Supplement: Promitor 70Roquette Glucidex 40 - Roquette Glucidex 2 - Pharmacosmos Dextran 10 - Promitor 70 |
| Sequence 2 | Experimental | Dietary Supplement: Roquette Glucidex 2, Dietary Supplement: Pharmacosmos Dextran 10, Dietary Supplement: Roquette Glucidex 40, Dietary Supplement: Promitor 70Roquette Glucidex 2 - Promitor 70 - Roquette Glucidex 40 - Pharmacosmos Dextran 10 |
| Sequence 3 | Experimental | Dietary Supplement: Roquette Glucidex 2, Dietary Supplement: Pharmacosmos Dextran 10, Dietary Supplement: Roquette Glucidex 40, Dietary Supplement: Promitor 70Promitor 70 - Pharmacosmos Dextran 10 - Roquette Glucidex 2 - Roquette Glucidex 40 |
| Sequence 4 | Experimental | Dietary Supplement: Roquette Glucidex 2, Dietary Supplement: Pharmacosmos Dextran 10, Dietary Supplement: Roquette Glucidex 40, Dietary Supplement: Promitor 70Pharmacosmos Dextran 10 - Roquette Glucidex 40 - Promitor 70 - Roquette Glucidex 2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female participant
- Healthy status (based on anamnesis)
- Age between 18 and 45 years
- BMI between 18.5 and 29.9 kg/m2
- Able to understand and sign an informed consent form
Key exclusion criteria (8 listed)
- Any known metabolic disease including diabetes or drug chronic intake (aspirin, vitamin C and mineral supplements, steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics…) possibly impacting (to the opinion of the medical responsible): The digestion or absorption of nutrients, the postprandial glucose response
- Major medical/surgical event requiring hospitalization in the last 3 months
- Pregnancy or lactation
- Known food allergy and intolerance
- Medically known cutaneous hypersensitivity to adhesives, silicon watch-strap and plasters
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 |
|---|---|---|
| Roquette Glucidex 2Roquette Glucidex 2: Maltodextrins with high degree of polymerization | Dietary supplement | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Pharmacosmos Dextran 10Pharmacosmos Dextran 10: Dextran with high degree of polymerization | Dietary supplement | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Roquette Glucidex 40Also: Positive controlRoquette Glucidex 40: Glucose syrup | Dietary supplement | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Promitor 70Also: Negative controlPromitor 70: Resistant Dextrin with a complex structure containing 70% non-digestible dietary fiber | Dietary supplement | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose
Time frame: From 0 (product intake) to 120 minutes
Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose in the interstitial subcutaneous fluid as measured by a continuous glucose monitoring (Flash Glucose Monitoring FGM) commercial device (Abbott Freestyle Libre), as absolute values or as relative value to the raise observed for a glucose syrup as positive control and a resistant dextrin containing a non-digestible fiber as negative control
6 secondary outcomes
Maximum concentration (Cmax) of post-prandial glucose
Time frame: From 0 (product intake) to 120 minutes
Time of Cmax (Tmax) of post-prandial glucose
Time frame: From 0 (product intake) to 120 minutes
Adverse events
Time frame: Through subject participation, up to 2 weeks
Gastro-intestinal tolerability
Time frame: Through subject participation, up to 2 weeks
Heart rate
Time frame: Through subject participation, up to 2 weeks
Physical activity
Time frame: Through subject participation, up to 2 weeks
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 4 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Postprandial Glucose Response
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Sex Differences in Metabolism Following a High-fat Meal
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A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
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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.
Pamela Sun, MD principal investigator
Nestlé Research - Clinical Research Unit - Clinical Innovation Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roquette Glucidex 2, Pharmacosmos Dextran 10 and Roquette Glucidex 40 in people with Postprandial Glucose Response, 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 8 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 4 Mar 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?
Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose (time frame: From 0 (product intake) to 120 minutes). 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 4 Mar 2022.