University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology
Bonn, North Rhine-Westphalia, 53115, Germany
NCT Number: NCT06270901
The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.
Looking for future studies?
Notify Me50 year–75 year
All sexes
Interventional
Not applicable
Bonn, North Rhine-Westphalia, 53115, Germany
In a randomized crossover design, 30 older men and women with increased risk for cardiometabolic diseases consume 4 mixed meals, which differ in dietary pattern, protein source and protein quantity. Two meals are designed according to the Planetary Health Diet with legumes as primary protein source whereas the other two meals are designed according to the Western Diet with animal food as primary protein source. Two meals are designed as high protein meals (62 g of protein) and two meals are designed as low protein meals (36 g of Protein). Therefore, participants consume 4 different test meals, a Low and a High Protein Western Diet Meal and a Low and a High Protein Planetary Health Diet Meal in a randomized order. During a postprandial observation period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6) and vascular function (e.g., pulse wave velocity) are analysed. Furthermore, amino acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin) are investigated. Each intervention will be separated by a washout period of approximately 14 days.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Planetary Health Diet Meal with 62 g of protein primarily from plant origin
Planetary Health Diet Meal with 36 g of protein primarily from plant origin
Western Diet Meal with 62 g of protein primarily from animal origin
Western Diet Meal with 36 g of protein primarily from animal origin
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Triglycerides (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Total cholesterol (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
LDL cholesterol (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
HDL cholesterol (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Free fatty acids (mmol/L)
Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Glucose (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Insulin (nmol/L)
Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
cPeptide (pg/mL)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
GLP-1 (pg/mL)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Glucagon (pg/mL)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Amino acid profile in blood (nmol/mL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Urea in blood (mg/dL)
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Uric acid in blood (mg/dL)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
e.g. Ghrelin (pg/mL)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
e.g. ADMA (µmo/L)
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
e.g. IL-6 (pg/mL)
Time frame: Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
e.g. pulse wave velocity (m/s)
Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
Assessment of hunger and satiety via a visual analogue scale (e.g. 0 = not hungry at all to 10 = very hungry)
Time frame: Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)
Assessment of attention via questionnaire (paper pencil test, e.g. higher amount of marked target items = higher attention, maximum points 640 = every target items marked correctly, minimum points: 0 = no target items marked or only wrong items marked)
Time frame: Postprandial period of 6 hours (T=0.5, 3, 6 hours)
Assessment of memory via questionnaire (paper pencil, e.g. higher reproduction of memorised visual and verbal information = better memory; visual part: maximum points: 31 = all visual information memorised, minimum points: 0 = no visual information memorised; verbal part: maximum points: 24 = all verbal information memorised, minimum points: 0 = no verbal information memorised)
University of Bonn
Other
Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolic Response in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases
Acronym: LeguPlan_1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06461273
Behavior, Body Weight
Newark, New Jersey, United States
View Trial DetailsNCT06186102
Arterial Occlusive Diseases, Arteriosclerosis
Aarhus, Jutland, Denmark
View Trial DetailsNCT04922970
Cardiovascular Diseases, Glucose Metabolism Disorders
Copenhagen, Denmark
View Trial DetailsNCT04748835
Behavior, Behavior, Animal
Dallas, Texas, United States
View Trial Details