Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response

Postprandial Glucose Response Clinical Trial

Official title:

Effect of Degree of Polymerization and Linkage of α-glucans on Post-prandial Glucose Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05266690
• Other study ID #: 19.10.NRC
• Status: Completed
• Phase: N/A
• Start date: November 29, 2019
• Est. completion date: February 18, 2020

Study information

• Verified date: March 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

• Smokers

• Participant having a hierarchical link with the research team members

Related Conditions & MeSH terms

• Postprandial Glucose Response

Intervention

Dietary Supplement:
• Roquette Glucidex 2
Roquette Glucidex 2: Maltodextrins with high degree of polymerization
• Pharmacosmos Dextran 10
Pharmacosmos Dextran 10: Dextran with high degree of polymerization
• Roquette Glucidex 40
Roquette Glucidex 40: Glucose syrup
• Promitor 70
Promitor 70: Resistant Dextrin with a complex structure containing 70% non-digestible dietary fiber

Locations

Country	Name	City	State
Switzerland	Nestlé Research - Clinical Research Unit - Clinical Innovation Lab	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	From 0 (product intake) to 120 minutes
Secondary	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
Secondary	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
Secondary	Heart rate	Continuous heart rate measure (recorded by wearable activity tracker)	Through subject participation, up to 2 weeks
Secondary	Physical activity	Continuous physical activity measure (recorded by wearable activity tracker)	Through subject participation, up to 2 weeks