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临床试验/NCT06701968
NCT06701968招募中不适用

A Healthy Nordic Diet to Reduce the Progression of Atherosclerosis in Individuals with Coronary Heart Disease: a Secondary Prevention Trial

Uppsala University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Change in coronary plaque volume

研究概览

简要总结

Diet can play a key role in atherosclerosis and coronary heart disease (CHD), but little interventional data exists, and the mediators of possible anti-atherosclerotic effects of diet are unclear. The investigators will investigate if a healthy Nordic diet (HND) reduces plaque volume, coronary artery calcification (CAC), and plaque inflammation (FAI) in CHD, and examine if changes in gut microbiota may be linked to plaque progression over time. The investigators will also explore if the diet response can be predicted by the metabolic phenotype.

In total 150 CHD patients is randomized to a HND rich in unsaturated fat and fibre from plants, or to a "usual care diet" for 18 months. Plaque volume and composition is assessed by CT, and fecal microbiota composition is determined by deep metagenome shotgun sequencing. CHD and metabolic risk factors, liver fat, muscle fat and biomarkers of diet adherence (plasma fatty acids, whole-grain metabolites) are measured. Machine-learning is used to identify diet "responders" on plaque progression, based on the individual microbiome and metabolome.

If a HND reduces plaque progression, this would be novel information of clinical importance. Also, if the diet alters microbiota that are linked to plaque progression, this would be of high scientific interest. Finally, potential prediction of the diet-response would open up for more personalized treatment of atherosclerosis.

详细描述

Atherosclerosis of coronary arteries is the main cause of coronary heart disease (CHD). In atherosclerosis, atherogenic lipids are deposited in the arteries to form plaques, and the larger the plaque volume, the more narrowing of the vessel. It is now feasible to directly visualize clinically relevant changes in plaque volume and composition (e.g. calcification, lipid content) by modern computed tomography (CT) angiography. Diet is a cornerstone in both primary and secondary prevention, but it is still not clear if dietary intervention can reduce coronary plaque progression as assessed by modern imaging technique.

In the Nordic countries, a promising alternative to Mediterranean diets is the Healthy Nordic diet. Controlled trials conducted in various Nordic populations have shown that healthy Nordic diets cause reduction of several key CVD risk factors such as elevated blood lipids and blood pressure, hyperglycemia, and inflammation. The Healthy Nordic diet is mainly, but not exclusively, a plant-based diet that accord with the Nordic Nutrition Recommendations (NNR 2023), e.g. is rich in vegetable fats from oils, spreads, nuts and seeds, whole-grains from rye, barley and oats, legumes, vegetables, Nordic fruits and berries but with moderate portions (2-3 times per week) of fatty fish (e.g. Salmon). The effects of a Healthy Nordic diet in a secondary preventive setting and in particular the potential impact on atherosclerosis is yet unknown. The investigators hypothesize that a Healthy Nordic Diet has anti-atherosclerotic properties that can reduce the progress of atherosclerosis and reduce key CVD risk markers and inflammation in patients with a recent MI or chronic coronary syndrome (CCS). Further, the investigators hypothesize this diet will have favorable changes on the gut microbiota, which in turn can contribute to reduced coronary plaque progression.

The overall aim is to compare the ability of a Healthy Nordic Diet versus usual care dietary advice to influence coronary plaque volume and CVD risk after 18 months in patients with MI or with CCS.

The primary aim is to investigate if a Healthy Nordic Diet can reduce plaque volume after 18 months as compared with usual care and routine dietary and lifestyle advice, and secondary aims are to investigate dietary effects on plaque composition, coronary artery calcium (CAC) and coronary inflammation (perivascular fat, fat attenuation index), as well as on ectopic fat content (e.g. liver). Exploratory aims are to investigate the dietary effects on gut microbiota, as well as on metabolomic- lipidomic- and proteomic plasma profiles. In addition, the investigators will monitor blood glucose control using wearable continous glucose monitors (CGMs) as well as Actiheart monitors to record heart ECG and activity with multiple data endpoints.

This study, named NORDHEART, is a randomized, single-blinded, parallel study including a dietary intervention group and a control group, in individuals with diagnosed MI or CCS. The investigators aim to include n=150 individuals in this trial. The majority of participants will be recruited at the Uppsala University hospital but further Swedish recruitment center in mid Sweden might be added if the recruitment rate in Uppsala is slower than expected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • Diagnosis with MI from 2 weeks after diagnosis and with maximum 6 months after diagnosis
  • Diagnosis with CCS (e.g. stable angina pectoris)
  • Ages 50 to 80 years
  • BMI 25-40.

排除标准

  • Severe heart failure (NYHA classes III, IV)
  • Alcohol intake >20g/day
  • Unwillingness to follow a new prescribed diet for 18 months
  • Other diseases implying a short estimated life expectancy (e.g. severe malignant or kidney or liver disease, as judged by consenting physician).

结局指标

主要结局

Change in coronary plaque volume

时间窗: 18 months

Will be assessed by photon-counting CT angiography

次要结局

  • Change in coronary inflammation: Fat attenuation Index(18 months)
  • To investigate if a Healthy Nordic Diet can decrease progression of atherosclerosis Change in coronary artery calcium score (CACS)(18 months)
  • Change in ectopic fat (liver, heart, muscle)(18 months)
  • Change in blood glycemic control(6, 12 and 18 months)
  • Change in plasma LDL cholesterol(18 months)
  • Change in systolic and diastolic blood pressure(6, 12 and 18 months)
  • Incident cardiovascular events(18 and 30 months (12 month post intervention))
  • Change in hepatic fibrosis(18 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulf Risérus

Professor

Uppsala University

研究点 (1)

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