Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777746
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2022-12-27
Brief Title:
The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus A Randomized Controlled Trial
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
The Effect of an Online Plant-Based Dietary Program on Cardiovascular Risk Factors in Persons With Type 2 Diabetes Mellitus A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-03
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:
Plate-DM
Brief Summary:
Persons with Type 2 Diabetes T2D are at an increased risk of cardiovascular disease CVD and mortality Dietary changes are recommended by guidelines to treat T2D and reduce risk of CVD Plant-based diets eliminate certain ie vegetarian diet or eliminate all animal based products ie vegan diet Clinical trials with plant-based diets have not looked at incidence of CVD as a primary outcome but at intermediate outcomes of cardiovascular risk A meta-analysis of 8 trials including 369 persons with T2D found an effect of a plant-based diet on glycated hemoglobin HbA1c of -029 95 CI -045 -012 relative to mostly omnivorous low-fat diets or usual diet The 95CI ranged from what the authors had defined as clinically trivial to clinically relevant For lipids a network meta-analysis in persons with T2D compared the effect of a plant-based diet to a omnivorous low fat diet 274 patients allocated to a plant-based diet vs 2047 patients allocated to low fat diets Compared to omnivorous low fat diets the mean effect of plant-based diets on LDL-Cholesterol was -033 mmolL 95CI- 055 - 012 However the quality of the evidence for this estimate was graded as low mainly due to imprecision and within-study-bias Furthermore plant-based diets might reduce blood pressure BP However while vegetarian diets reduce BP in patients with and without hypertension for vegan diets the effect was only significant in patients with a systolic BP130mmHgz see section 143 Additionally the effect of plant-based diets on inflammation which might also be causally related to CVD risk in persons with T2D has not been reported in trials with persons with T2D Furthermore most clinical trials of plant-based diets in persons with T2D have used resource intensive interventions like weekly group meetings and cooking sessions The effect of an online plant-based dietary intervention which is more scalable has not been reported in clinical trials Lastly factors influencing adherence in these trials have not been reported
In summary plant-based diets likely lower CVD risk by lowering HbA1c LDL cholesterol and potentially blood pressure in persons with T2D However estimated effect sizes are imprecise and the effect on inflammation is still unknown Furthermore trials to date have used resource intensive interventions Thus the present trial aims to study the effect of a primarily online plant-based dietary program on cardiovascular risk factors in persons with T2D Additionally adherence and factors influencing adherence will be investigated Participants will be randomized to the intervention or control group The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions Researchers will compare the intervention group to the control group that continues with usual diet to see if the cardiovascular risk profile of the intervention group improves
In summary plant-based diets likely lower CVD risk by lowering HbA1c LDL cholesterol and potentially blood pressure in persons with T2D However estimated effect sizes are imprecise and the effect on inflammation is still unknown Furthermore trials to date have used resource intensive interventions Thus the present trial aims to study the effect of a primarily online plant-based dietary program on cardiovascular risk factors in persons with T2D Additionally adherence and factors influencing adherence will be investigated Participants will be randomized to the intervention or control group The intervention group will be guided to transition to a plant-based dietary pattern using an online platform and online sessions Researchers will compare the intervention group to the control group that continues with usual diet to see if the cardiovascular risk profile of the intervention group improves
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None