Clinical trial NCT05951140: Personalised Nutrition for Healthy Living
Official title: Personalised Nutrition for Healthy Living: PROTEIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2023-07-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The topic of diet and physical activity are of great importance in the treatment of T2D. In the daily routine of a practice or clinic, a doctor has an average of eight minutes per patient, leaving little time for lifestyle issues (Irving et al. 2017). An individualised procedure requires more time and therefore more resources. Currently, an app can be programmed with evidence-based information so that it provides appropriate personalised behavioural recommendations via machine learning. The user gets direct feedback and can make a behavioural change himself. On the one hand, this approach allows better use of doctor-patient time and, on the other hand, the patient learns through positive reinforcement in such a way that his or her behaviour change is supported and reinforced in the longer term and potentially sustainably.

The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. In addition, exploratory genetic and microbiome data will be explored to answer the question of personalisation of the recommendations.

Detailed description: An inadequate diet and increasing sedentary lifestyle are major contributors to the rise of non-communicable diseases. Individualized recommendations can lead to a healthier lifestyle. The scientific evidence of the effectiveness of health apps offering personalized recommendations is limited.

The aim of this intervention pilot study within the scope of the EU-Horizon 2020 project is to investigate lifestyle support through a mobile app and wearables to improve lifestyle (personalised nutrition) and important metabolic outcomes in patients with type 2 diabetes or prediabetes. The Investigators want to asess whether the use of this mobile application that incorporates information of wearables (continuous glucose monitoring and fitness tracker), improves lifestyle and metabolic outcomes in patients with type 2 diabetes (T2D) or prediabetes. Our primary outcome is to improve time in range (TIR) by 5%.

It is a prospective randomized control pilot trial with an intervention period of 12 weeks. Participants will use the Protein app, a continuous glucose monitoring system (CGM) and an activity tracker to collect real world data to enable personalisation.

In order to identify the effect of the PROTEIN-Application, 300 participants with T2DM or prediabetes will be randomly allocated into two groups: the (1) start-group or the (2) wait-group. The start-group will use an activity tracker, a CGM and the PROTEIN app for 12 weeks followed by a six-week period without the app, but they will use the wearables. The wait-group will use an activity tracker and a CGM, but not the PROTEIN app for six weeks followed by a period of 12 weeks using the PROTEIN app. This study design allowed us to have a control group within the whole cohort and clearly see the influence of the PROTEIN app.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Diabetes Type 2 or Prediabetes
* BMI: 20-kg kg/m2
* Android Smart Phone/ Tablet use
* In good physical health
* Able to provide written informed consent

Exclusion Criteria:

* Severe endocrine, gastrointestinal, metabolic, cardiovascular, pulmonary, inflammatory or psychiatric disorder
* Active or recent relevant cancer
* Currently receiving treatment with Insulin
* People with disordered eating (such as anorexia nervosa etc.)
* Those who are not be able to provide written consent

Primary outcomes:
measure: Improvement of Time In Range (TIR) by 5%
timeFrame: 12 Weeks
measure: Improve eating behavior towards healthier choices
timeFrame: 12 Weeks
Secondary outcomes:
measure: Adherence to dietary recommendations of the app
timeFrame: 12 Weeks
measure: Improvement of glycaemic metabolism
timeFrame: 12 Weeks
measure: Reduction in sedentary time
timeFrame: 12 Weeks
measure: Aproximation of the energy intake
timeFrame: 12 Weeks
measure: Measurable change in the faecal microbiome
timeFrame: 12 Weeks
measure: Calculation of the Polygenic Risk Score
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Univesitätsmedizin Berlin
Study officials:
affiliation: Information Technologies Institute, Centre for Research and Technology Hellas
name: Lazaros Gymnopoulos, Dr
role: STUDY_DIRECTOR
References: