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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Roquette Glucidex 40 - Roquette Glucidex 2 - Pharmacosmos Dextran 10 - Promitor 70 |
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| Sequence 2 | Experimental | Roquette Glucidex 2 - Promitor 70 - Roquette Glucidex 40 - Pharmacosmos Dextran 10 |
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| Sequence 3 | Experimental | Promitor 70 - Pharmacosmos Dextran 10 - Roquette Glucidex 2 - Roquette Glucidex 40 |
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| Sequence 4 | Experimental | Pharmacosmos Dextran 10 - Roquette Glucidex 40 - Promitor 70 - Roquette Glucidex 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roquette Glucidex 2 | Dietary Supplement | Roquette Glucidex 2: Maltodextrins with high degree of polymerization |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From 0 (product intake) to 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of post-prandial glucose | Maximum concentration (Cmax) of post-prandial glucose in the interstitial subcutaneous fluid as measured by FGM device | From 0 (product intake) to 120 minutes |
| Time of Cmax (Tmax) of post-prandial glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Sun, MD | Nestlé Research - Clinical Research Unit - Clinical Innovation Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nestlé Research - Clinical Research Unit - Clinical Innovation Lab | Lausanne | Canton of Vaud | 1000 | Switzerland |
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Monocentric, controlled, randomized, double-blind, complete 4x4 cross-over clinical trial
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Individual coding
| Pharmacosmos Dextran 10 | Dietary Supplement | Pharmacosmos Dextran 10: Dextran with high degree of polymerization |
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| Roquette Glucidex 40 | Dietary Supplement | Roquette Glucidex 40: Glucose syrup |
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| Promitor 70 | Dietary Supplement | Promitor 70: Resistant Dextrin with a complex structure containing 70% non-digestible dietary fiber |
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Time of Cmax (Tmax) of post-prandial glucose in the interstitial subcutaneous fluid as measured by FGM device |
| 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 | 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 | Through subject participation, up to 2 weeks |
| Heart rate | Continuous heart rate measure (recorded by wearable activity tracker) | Through subject participation, up to 2 weeks |
| Physical activity | Continuous physical activity measure (recorded by wearable activity tracker) | Through subject participation, up to 2 weeks |