Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Incremental area under the concentration curve (iAUC 0 to 120 minutes) of post-prandial glucose
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Individual coding
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •Participant having a hierarchical link with the research team members
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Time of Cmax (Tmax) of post-prandial glucose(From 0 (product intake) to 120 minutes)
- Physical activity(Through subject participation, up to 2 weeks)
- Maximum concentration (Cmax) 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)