NCT05382533

MoKaRi II Intervention Study

Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose \> 5.6 ≤ 7 mmol/l).

Detailed description

The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance (glucose \> 5.6 ≤ 7 mmol/l). The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D). The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products. Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D). The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.

Conditions

• Decreased Cardovascular Risk
• Decreased Risk of Diabetes Mellitus Type II

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Menu plans	The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-08-31
• Completion: 2022-12-14
• First posted: 2022-05-19
• Last updated: 2023-02-06

Locations

1 site across 1 country: Germany