Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response
1 other identifier
interventional
10
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2020
CompletedFirst Submitted
Initial submission to the registry
February 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 4, 2022
CompletedMarch 4, 2022
March 1, 2022
3 months
February 7, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Maximum concentration (Cmax) of post-prandial glucose
From 0 (product intake) to 120 minutes
Time of Cmax (Tmax) of post-prandial glucose
From 0 (product intake) to 120 minutes
Adverse events
Through subject participation, up to 2 weeks
Gastro-intestinal tolerability
Through subject participation, up to 2 weeks
Heart rate
Through subject participation, up to 2 weeks
- +1 more secondary outcomes
Study Arms (4)
Sequence 1
EXPERIMENTALRoquette Glucidex 40 - Roquette Glucidex 2 - Pharmacosmos Dextran 10 - Promitor 70
Sequence 2
EXPERIMENTALRoquette Glucidex 2 - Promitor 70 - Roquette Glucidex 40 - Pharmacosmos Dextran 10
Sequence 3
EXPERIMENTALPromitor 70 - Pharmacosmos Dextran 10 - Roquette Glucidex 2 - Roquette Glucidex 40
Sequence 4
EXPERIMENTALPharmacosmos Dextran 10 - Roquette Glucidex 40 - Promitor 70 - Roquette Glucidex 2
Interventions
Roquette Glucidex 2: Maltodextrins with high degree of polymerization
Pharmacosmos Dextran 10: Dextran with high degree of polymerization
Roquette Glucidex 40: Glucose syrup
Promitor 70: Resistant Dextrin with a complex structure containing 70% non-digestible dietary fiber
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nestlé Research - Clinical Research Unit - Clinical Innovation Lab
Lausanne, Canton of Vaud, 1000, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Sun, MD
Nestlé Research - Clinical Research Unit - Clinical Innovation Lab
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Individual coding
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2022
First Posted
March 4, 2022
Study Start
November 29, 2019
Primary Completion
February 18, 2020
Study Completion
February 18, 2020
Last Updated
March 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share