Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response
Condition: Postprandial Glucose Response
Study type: Interventional

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:

        -  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.
    

Intervention name(s): Roquette Glucidex 2; Pharmacosmos Dextran 10; Roquette Glucidex 40; Promitor 70
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Other intervention name(s): Positive control; Negative control
Intervention MeSH terms: Dextrans
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Monocentric, controlled, randomized, double-blind, complete 4x4 cross-over clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Postprandial glucose response; α-glucans; Polymerization; Decentralized study design