Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Participants with Increased Cardiometabolic Risk

Официальное название

Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases

Обзор

The aim of the study is to systematically investigate the effects of a diet enriched with legumes in a dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires.

Подробное описание

The aim of the study is to systematically investigate the effects of a diet enriched with legumes in the dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires. The subjects come to the study center for examination before the start of the intervention (visit 1), after three weeks (mid-intervention, visit 2) and after six weeks (end of intervention, visit 3).

Вмешательства

• Другое legume-rich Planetary Health Diet
  legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
• Другое control diet based on Western Diet low in legumes
  diet based on the Western dietary pattern including animal protein sources (= control diet)

Первичные конечные точки

• Pameters of glucose metabolism in blood [Срок оценки: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention]

Вторичные конечные точки (12)

• Parameters of glucose metabolism in blood [Срок оценки: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention]
• Parameters of glucose metabolism in blood [Срок оценки: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention]
• Parameters of glucose metabolism in blood [Срок оценки: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention]
• Parameters of glucose metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of glucose metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]
• Parameters of lipid metabolism in blood [Срок оценки: Fasting (t=0) in week 1 and week 6 of intervention]

Критерии участия

Критерии включения

• written informed consent
• Non-smoking
• BMI: 27 - 34,9 kg/m2
• Waist circumference (women ≥ 80 cm, men ≥ 94 cm)
• Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg
• At least one of the following criteria:
• Fasting triglycerides in serum: ≥ 150 mg/dL
• Fasting LDL cholesterol in serum ≥160 mg/dL
• Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL
• Fasting glucose in plasma: ≥ 100 mg/dL
• CRP in serum 0,2-3 mg/dL

Критерии исключения

• food intolerances and allergies (especially legumes)
• Smoking
• malabsorption syndromes
• thyroid diseases
• impaired renal function
• chronic liver disease
• heart failure
• myocardial infarction
• insulin-dependent diabetes mellitus
• chronic inflammatory diseases
• tumors
• anemia
• immunosuppression
• intake of supplements (e.g., fish oil)
• Participation in another study
• other exclusion criteria at the discretion of the physician/ investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• Institute of Nutritional and Food Sciences, Nutrition Physiology — Bonn

Идентификаторы

NCT: NCT06700954 · BMEL: 2822EPS008 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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