Metabolic status in overweight adults (lipid and carbohydrate metabolism)
Conditions
Interventions
Group 1: Diet including traditionally prepared dishes made from whole pulses (at least 130 g pulses/day
daily for 4 weeks). These are processed using standard household methods (e.g., chickpea curry, bean soup, hummus)
at least 130 g pulses/day, 4 weeks after a 2-week run-in phase of pulses abstinence
Group 2: Diet including at least 130 g pulses/day, daily for 4 weeks in a more processed form (e.g., pulse flour). T
Sponsors
Max Rubner-Institut, Bundesforschungsinstitut für Ernährung und Lebensmittel, Studienzentrum für Humanernährung
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Women and men - BMI = 25 kg/m² - Waist circumference = 94 cm for men, = 80 for women - Volunteers who are able to comply with the study requirements - Parameters of liver and kidney function without pathological significance - Normal thyroid function or euthyroid status in treated thyroid disorders - Non-smokers - Omnivorous diet (mixed eater) - Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: - Diseases affecting absorption, digestion, metabolism, or excretion of nutrients - Diabetes mellitus - Acute or chronic infectious diseases - Tumors requiring therapy - History of bariatric surgery - History of gastrointestinal tract surgery affecting absorption, digestion, metabolism, or excretion of nutrients - History of pancreas surgery - History of cholecystectomy - Intake of cholesterol-lowering medication - Acute/regular intake of medication resulting in energy or nutrient malabsorption - Allergy/intolerance to any food or food components of the dietary intervention - Use of antibiotics < 10 weeks prior to study entry - Blood donation during or < 2 weeks prior to study entry - Pregnancy or breastfeeding - Drug, alcohol, or drug abuse - Participation in other clinical trials that may effect the outcome of this study - Individuals living in a care facility - Individuals deprived of their liberty by court or administrative order - Individuals who are not expected to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total serum cholesterol concentration over the intervention. Total serum cholesterol levels will be determined by standard lab methods at the beginning and at the end of the 4-week intervention. Concentration changes between the three intervention groups are compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in additional parameters of lipid and carbohydrate metabolism, determined in blood and urine samples at the beginning and at the end of the 4-week intervention Changes in metabolites such as bile acids and short-chain fatty acids; application of targeted and untargeted analytical methods (LC-MS, GCxGC-MS, NMR) in blood and urine samples at the beginning and at the end of the 4-week intervention. Changes in metabolic regulators such as the satiety hormone GLP-1 in blood (ELISA, at the beginning and at the end of the 4-week intervention). Effects on glucose metabolism: Performance of an oral glucose tolerance test (OGTT) at the beginning and at the end of the 4-week intervention (blood glucose and insulin profile). Effects on gut microbiota composition (16S rRNA sequencing, shotgun metagenome sequencing) and on microbial metabolic products (GC, LC-MS, NMR) in stool samples (collected before the beginning and at the end of the 4-week intervention). Gastrointestinal symptoms (during the 4-week intervention: weekly recording, gastrointestinal symptoms questionnaire). Impact on intestinal barrier integrity (quantification of lipopolysaccharide-binding protein (LBP) as surrogate marker, quantification in blood via ELISA, at the beginning and at the end of the 4-week intervention). Assessment of habitual dietary intake, covering the preceding 4 weeks before start of intervention (food frequency questionnaire, FFQ) Anthropometry and body composition (weight, hip and waist circumference, waist-to-hip-ratio, body composition via bioelectrical impedance analysis; measurements at the beginning of run-in and at the beginning and the end of the 4-week intervention). | — |
Countries
Germany
Contacts
Public ContactJulia Renz
Max Rubner-Institut, Bundesforschungsinstitut für Ernährung und Lebensmittel, Studienzentrum für Humanernährung
Outcome results
None listed