Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05382533
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2022-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MoKaRi II Intervention Study
Sponsor:
University of Jena
Organization:
Study Overview
Official Title:
Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoKaRi II
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: