This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
Growing evidence highlights the role of the individual diet and gut microbiome in modulating human metabolism, inflammatory status and cardiovascular risk. This scenario supports nutritional approaches targeted to modify gut microbiota composition to trigger health benefits and the interest to develop novel functional foods enriched with probiotics. Most of commercial probiotic foods are in the category of dairy products and contain Lactobacillus strains. Besides that, Bacillus spp. along with the ability to form spores show probiotic attributes by exhibiting pathogen exclusion and antioxidant, antimicrobial and immune-modulatory abilities. Furthermore, they possess a stronger viability and stability to withstand high temperature processes, such as baking and boiling, than other probiotic bacteria thus representing an ideal choice for the development of functional cereal-based products. In particular, Bacillus clausii UBBC07 exhibits probiotic properties by alleviating the severity and symptoms of acute diarrhoea in adults and children and show a high stability over a wide range of temperatures with potential applications in a variety of formulations and foods. The health benefits of B. clausii UBBC07 in overweight and obese subjects is unexplored. This study aims to investigate the effects of consumption for 4 weeks of a probiotic durum wheat pasta enriched with spores of B. clausii UBBC07 vs a conventional durum wheat pasta (control) on metabolic and inflammatory status, on gut permeability and functionality, on daily energy intakes, appetite feelings, body weight, body mass index (BMI), waist and hip circumferences, blood pressure, body composition and wellbeing status in overweight and obese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Subjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
Subjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
Department of Agricultural Sciences
Portici, Italy, Italy
Changes in fasting inflammatory blood markers
Measure of plasma C-reactive protein (mmol/L)
Time frame: 1 months
Changes in fasting plasma lipids
Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol, as well as Triglycerides
Time frame: 1 months
Changes in fasting plasma glucose
Measure of plasma glucose concentrations (mg/dL)
Time frame: 1 months
Changes in small intestine permeability
Measure of lactulose and mannitol excreted in urines collected in the 0-5 hours time interval after an oral challenge with 5 g lactulose, 2 g mannitol and 2 g sucralose dissolved in 100 mL of water. The amounts of lactulose and mannitol excreted will be expressed in milligrams, and their ratio (lactulose/mannitol) will be calculated and used as marker of small intestine permeability
Time frame: 1 month
Changes in colonic permeability
Measure of sucralose excreted in urines collected over 24 hours after an oral challenge with 5 g lactulose, 2 g mannitol and 2 g sucralose dissolved in 100 mL of water. The amount of sucralose excreted will be expressed in milligrams and will be used as marker of colonic permeability
Time frame: 1 month
Changes in stool consistency
Measure of consistency of feces by mean of King's stool chart filled out by subjects. The chart comprises four categories of stool consistency: hard and formed, soft and formed, loose and unformed, liquid.
Time frame: 1 month
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Changes in stool weight
Measure of stool weight by mean of King's stool chart filled out by subjects. The chart comprises three categories of stool weight : \<100 g, 100-200 g, \>200 g.
Time frame: 1 month
Changes in stool frequency
Measure of frequency of feces by mean of King's stool chart filled out by subjects. Fecal frequency is incorporated by recording the code of each feces passed over a 24 hour period.
Time frame: 1 month
Changes in gastrointestinal functionality
Calculation of daily fecal score from summation of all scores for stool consistency, weight and frequency obtained from King's stool chart filled out by subjects. Scores are weighted such that an increase in fecal frequency alone results in a higher score than a change in fecal consistency alone, which in turn results in a higher score than an increase in fecal weight alone. Diarrhea is classified by a daily fecal score of 15 or more.
Time frame: 1 month
Changes in faecal microbiome
The composition of faecal microbiome will be determined by high throughput sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene. The massive number of sequences obtained will be analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species occurring in each sample will be determined.
Time frame: 1 month
Variation of plasma glucagon like peptide-1 concentration
Measure of plasma glucagon like peptide-1 concentrations (mg/dL)
Time frame: 1 month
Variation of plasma gastric inhibitory polypeptide hormone concentration
Measure of plasma gastric inhibitory polypeptide concentrations (mg/dL)
Time frame: 1 month
Variation of plasma Glucagon hormone concentration
Measure of plasma Glucagon concentrations (mg/dL)
Time frame: 1 month
Variation of plasma Ghrelin hormone concentration
Measure of plasma Ghrelin concentrations (mg/dL)
Time frame: 1 month
Variation of plasma Insulin hormone concentration
Measure of plasma Insulin concentrations (mg/dL)
Time frame: 1 month
Variation of plasma endocannabinoids and N-acyl-ethanolamines concentration
Measure of plasma endocannabinoids and N-acyl-ethanolamines concentrations (mg/dL)
Time frame: 1 month
Variation of serum dipeptidyl-dipeptidase-IV activity
Measure of activity of dipeptidyl-dipeptidase-IV activity (U/L)
Time frame: 1 month
Changes in body weight
Measure of body weight in fasting subjects
Time frame: 1 month
Changes in body mass index
Calculation of body mass index by the formula weight in kilograms divided by height in meters squared.
Time frame: 1 month
Changes in waist circumference
Measure of waist circumference at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest, with the tape parallel to the floor.
Time frame: 1 month
Changes in hip circumference
Measure of hip circumference around the widest portion of the buttocks, with the tape parallel to the floor.
Time frame: 1 month
Changes in blood pressure
Measure of systolic pressure and diastolic pressure in millimetres of mercury (mmHg) by using a digital sphygmomanometer
Time frame: 1 month
Changes in body composition
Body composition 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.
Time frame: 1 month
Variation of daily energy intakes
Calculation of total daily energy intakes based on 7 days food records
Time frame: 1 month
Variation of hunger sensation scores
Measures of hunger sensation 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.
Time frame: 1 month
Variation of fullness sensation scores
Measure of fullness sensation over the day reported by subjects by using fullness Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating fullness.
Time frame: 1 month
Variation of satiety sensation scores
Measure of satiety sensation over the day reported by subjects by using satiety Visual Analogue Scales (VAS) 0-10 centimeters. Changes in these scores may reflect potential effects of dietary intervention in modulating satiety.
Time frame: 1 month
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) 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.
Time frame: 1 month