Lifestyle-related Condition Clinical Trial
— LEGUMINIBUSOfficial title:
Discovering the Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
The goal of this clinical trial is to investigate the effects of replacing red meat with pulses, on cardiometabolic health and gut microbiome in individuals with unhealthy habits and sedentary lifestyles at high risk for cardiovascular diseases. The main questions it aims to answer are: 1. How does the substitution of red meat with pulses affect some markers of cardiovascular risk? 2. How does this dietary intervention influence the composition and function of the gut microbiome, nutritional status, well-being indices, and biomarkers related to metabolic, oxidative, inflammatory, immune, and intestinal permeability status? Participants will: - be assigned to either the Pulses Diet (PulD) group or the Plant Proteins Diet (PPD) group or the Habitual diet (HabD) group; - follow their habitual diet (HabD) or the prescribed dietary plan designed on individual habitual diet to be isocaloric and isoprotein but replacing red meat with pulses (PulD group) or a combination of pulses and plant-based meat substitutes (PPD group); - keep their physical activity levels unchanged during the entire intervention period; - be required to complete 7-day food diaries and associated questionnaires on appetite, along with additional questionnaires related to physical activity levels, overall well-being, mood, sleep quality, stool frequency and consistency at each nutritional intervention time-point. Researchers will compare PulD, PPD, and HabD to assess if the dietary interventions have an impact on cardiometabolic health and gut microbiome.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | October 16, 2024 |
Est. primary completion date | October 16, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - men and women aged 18-65; - 20 = BMI = 35 kg/m2; - habitual diet characterized by = 3 medium servings of fresh red meat or processed meat (equivalent to a portion weight of 100g of fresh meat and 50g of cured meats); - habitual diet without probiotics, functional foods, and/or any type of food supplements; - low level of physical activity (sedentary lifestyle); - signing the informed consent form and expressing consent for the processing of personal data. Exclusion Criteria: - Food allergies and intolerances, such as celiac disease, lactose intolerance, and others; - Gastrointestinal disorders of any kind; - Significant medical conditions; - Pregnancy or breastfeeding; - Hypertriglyceridemia (Triglycerides > 200 mg/dL); - Hypercholesterolemia (Cholesterol > 200 mg/dL); - Diabetes (Blood glucose = 126 mg/dL); - Hypertension (Blood pressure > 140/90 mm Hg); - Weight loss = 3 kg in the past 2 months prior to the study; - Use of any medication at enrollment and in the 2 months prior to the study; - Regular diet rich in fruits and vegetables; - Consumption of alcohol equivalent to or exceeding 3 glasses of wine per day; - Concurrent participation in other clinical trials. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Agricultural Sciences, Federico II University | Portici |
Lead Sponsor | Collaborator |
---|---|
Paola Vitaglione |
Italy,
Crimarco A, Springfield S, Petlura C, Streaty T, Cunanan K, Lee J, Fielding-Singh P, Carter MM, Topf MA, Wastyk HC, Sonnenburg ED, Sonnenburg JL, Gardner CD. A randomized crossover trial on the effect of plant-based compared with animal-based meat on trim — View Citation
Meslier V, Laiola M, Roager HM, De Filippis F, Roume H, Quinquis B, Giacco R, Mennella I, Ferracane R, Pons N, Pasolli E, Rivellese A, Dragsted LO, Vitaglione P, Ehrlich SD, Ercolini D. Mediterranean diet intervention in overweight and obese subjects lowe — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in fasting total cholesterol concentration | Measure of serum total cholesterol concentration (mg/dL serum) | 2 months | |
Primary | Changes in plasma TMAO concentration | Measure of plasma TMAO concentration (µmol/L plasma) | 2 months | |
Secondary | Changes in faecal microbiome | Measure of faecal microbiome | 2 months | |
Secondary | Changes in urinary TMAO concentration | Measure of urinary TMAO concentration (mmol/mol creatinine) | 2 months | |
Secondary | Changes in urinary polyphenols concentration | Measure of urinary polyphenols concentration (ng/mg creatinine) | 2 months | |
Secondary | Changes in urinary urolithin concentration | Measure of urinary urolithin concentration (ng/mg creatinine) | 2 months | |
Secondary | Changes in urinary betaine concentration | Measure of urinary betaine concentration (mmol/mol creatinine) | 2 months | |
Secondary | Changes in urinary carnitine concentration | Measure of urinary carnitine concentration (mmol/mol creatinine) | 2 months | |
Secondary | Changes in urinary choline concentration | Measure of urinary choline concentration (mmol/mol creatinine) | 2 months | |
Secondary | Changes in urinary tryptophan betaine concentration | Measure of urinary tryptophan betaine concentration (mmol/mol creatinine) | 2 months | |
Secondary | Changes in urinary indican concentration | Measure of urinary indican concentration (mg/g creatinine) | 2 months | |
Secondary | Changes in urinary creatinine concentration | Measure of urinary concentration (mg/dL) | 2 months | |
Secondary | Variation of complete blood count | Measure of Red blood cell (RBC) count (number of cells/mm3); Hemoglobin (Hb) concentration (g/dL); Hematocrit (HCT) percentage (%); White blood cell (WBC) count (number of cells/mm3); Platelet (PLT) count (number of cells/mm3). | 2 months | |
Secondary | Variation of blood iron status biomarkers | Measure of blood concentrations (mg/dL) of iron, ferritin, total transferrin | 2 months | |
Secondary | Variation of vitamin B status | Measure of blood folic acid and vitamin B12 concentrations (ng/mL) | 2 months | |
Secondary | Variation of individual hormonal status | Measure of plasma glucagon-like peptide 1 (GLP-1), Glucose-dependent Insulinotropic Peptide (GIP), Glucagon, Leptin, Ghrelin, C-peptide concentrations (pg/mL plasma) | 2 months | |
Secondary | Variation of plasma endocannabinoids concentration | Measure of plasma endocannabinoids concentration (ng/mL) | 2 months | |
Secondary | Variation of plasma N-acylethanolamines concentration | Measure of plasma N-acylethanolamines concentration (ng/mL) | 2 months | |
Secondary | Changes in plasma betaine concentration | Measure of plasma betaine concentration (µmol/L plasma) | 2 months | |
Secondary | Changes in plasma carnitine concentration | Measure of plasma carnitine concentration (µmol/L plasma) | 2 months | |
Secondary | Changes in plasma choline concentration | Measure of plasma choline concentration (µmol/L plasma) | 2 months | |
Secondary | Changes in plasma bioactive peptides concentration | Measure of plasma bioactive peptides concentration (ng/mL plasma) | 2 months | |
Secondary | Changes in plasma bile acids concentration | Measure of plasma bile acids concentration (ng/mL plasma) | 2 months | |
Secondary | Variation of plasma oxidative stress biomarkers | Measure in plasma of: TBARS concentration (µM); nitrotyrosine (N-Tyr) concentration (OD/mL); 8-hydroxy-2-deoxyguanosine (8-OHdG) concentration (ng/mL) | 2 months | |
Secondary | Variation of plasma antioxidant enzyme activities | Measure of plasma superoxide dismutase (SOD) activity (U/mL); catalase activity (nmol/min/mL); glutathione peroxidase (GPx) activity (nmol/min/mL) | 2 months | |
Secondary | Variation of serum dipeptidyl peptidase-IV (DPP-IV) concentration and activity | Measure of serum dipeptidyl peptidase-IV (DPP-IV) concentration (ng/mL) and activity (IU/L) | 2 months | |
Secondary | Variation of serum Triglycerides concentration | Measure of serum triglycerides concentration (mg/dL serum) | 2 months | |
Secondary | Variation of serum LDL- and HDL-cholesterol concentrations | Measure of serum LDL-, HDL-cholesterol concentrations (mg/dL serum) | 2 months | |
Secondary | Variation of serum glucose concentration | Measure of serum glucose concentration (mg/dL) | 2 months | |
Secondary | Variation of serum insulin concentration | Measure of serum insulin concentration (µU/mL serum) | 2 months | |
Secondary | Variation of serum Insulin-like Growth Factor-1 (IGF-1) concentration | Measure of serum IGF-1 concentration (ng/mL) | 2 months | |
Secondary | Variation of serum C-reactive protein (CRP) concentration | Measure of serum CRP concentration (mg/L) | 2 months | |
Secondary | Variation of serum zonulin concentration | Measure of serum zonulin concentration (ng/mL) | 2 months | |
Secondary | Changes in immune state blood markers | Measure of monocyte polarization (Arbitrary Units) of Cluster of Differentiation (CD) 86, Tumor Necrosis Factor alpha (TNFa), inducible Nitric Oxide Synthase (iNOS), CD36, CD11c, CD169, CD206, CD163, CD68, CD11b, CD16, e CD14 | 2 months | |
Secondary | Variation of erythrocytes antioxidant enzymes activity | Measure in erythrocytes of: superoxide dismutase (SOD) activity (U/mL); catalase activity (nmol/min/mL); glutathione peroxidase (GPx) activity (nmol/min/mL); glutathione reductase (GR) activity (U/mL) | 2 months | |
Secondary | Changes in body weight | Measure of body weight (kg) in fasting subjects | 2 months | |
Secondary | Changes in body mass index | Calculation of body mass index (kg/m2) by using the formula weight in kilograms divided by height in meters squared. | 2 months | |
Secondary | Changes in waist and hip circumferences | Measure of waist circumference (cm) at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest.
Measure of hip circumference (cm) around the widest portion of the buttocks. |
2 months | |
Secondary | Changes in blood pressure | Measure of systolic pressure and diastolic pressure in millimetres of mercury (mmHg) by using a digital sphygmomanometer | 2 months | |
Secondary | Changes in body composition | Body composition (kg body fat mass, body fat-free mass and total body water) is determined by conventional bioelectrical impedance analysis with a single-frequency 50 kilohertz (kHz) bioelectrical impedance analyzer in the postabsorptive state (fasting subjects) and after being in the supine position for 20 min. Body composition data will be calculated from bioelectrical measurements and anthropometric data by using validated predictive equations. | 2 months | |
Secondary | Variation of hunger, fullness and satiety sensation scores | Measures of hunger, fullness and satiety sensations over the day reported by subjects by using hunger Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating hunger, fullness and satiety. | 2 months | |
Secondary | Changes in stool weight, consistency and frequency | Measure of stool weight, frequency and consistency by mean of King's Stool Chart (KSC) filled out by subjects. The chart comprises three categories of stool weight : <100 g, 100-200 g, >200 g. The chart comprises four categories of stool consistency: hard and formed, soft and formed, loose and unformed, liquid. Fecal frequency is incorporated by recording the code of each feces passed over a 24 hour period. | 2 months | |
Secondary | Assessment of diet composition | Measure of individual's usual food consumption through Food Frequency Questionnaires (FFQ) by querying the frequency (times/week) and amount (g) at which the respondent consumed food items based on a predefined food list. | 2 months | |
Secondary | Changes in physical activity level | Measurement of an individual's physical activity level (MET min/week) through the International Physical Activity Questionnaire (IPAQ), which assesses the frequency (times/week) and duration (min) of different activities such as walking, moderate-intensity exercises, vigorous-intensity exercises, and sitting time. | 2 months | |
Secondary | Variation of wellbeing status | Estimate of wellbeing status by mean of quality of life (QoL) questionnaire, which is based on Short Form-12 Health Survey (SF-12), a self-report form of subjective health. Physical and Mental Health Composite Scores (PCS & MCS, arbitrary units) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | 2 months |
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