Measuring the Impact of Dietary Supplementation With a New Baking Product on Gut Microbiota and Cholesterol Metabolism
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|ClinicalTrials.gov Identifier: NCT02664428|
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : January 12, 2017
Study hypothesis: Diet integrated with food prepared with olive, buckwheat, peas and chestnut flour as in PreBIOil product combination can modify the gut microbiota and the cholesterol metabolism.
Primary objectives of the study are to assess whether the test product to be able to change:
- fecal microbiota profile;
- Plasma cholesterol LDL, total, total LDL and HDL ratio;
- plasma triglycerides;
- Apolipoprotein ApoA-I, ApoB, and Lp.
Secondary objectives of the study are:
- anthropometric indices;
- secondary metabolites of polyphenols in human biofluids;
- mass spectrometry plasma and urine metabolite profile;
- blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC);
7) urinary isoprostane F2; 8) oxidized LDL in plasma.
Study Design: placebo-controlled, randomized, double-blind parallel trial.
Inclusion criteria: Aged 30-65 years; BMI 20-29,9 kg/m^2. Total Cholesterol 180-240 mg/dl
Exclusion criteria: Fasting blood glucose >150 mg/dl; triglycerides >500 mg/dl; uncontrolled hypertension (blood pressure [BP] >160/100 mm Hg under antihypertensive therapy); any long term medical therapy; food intolerances; alcohol intake >5 drinks per day or use of narcotic substances; use of dietary supplements, pro or pre- biotics; special diet; pregnancy, tobacco smoking.
Methodology: Determination of eligibility: for each volunteer aged between 30 and 65 years, will undergo to clinical and biochemistry evaluation. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at visit T-1 at the Casa di Cura Eremo di Arco (TN). In this T-1 visit the eligibility will be established and the participants will be randomized to receive supplementation with either PreBIOil biscuit (90g/day) or Control for 8 weeks in a double-blind manner. Clinical tests, blood drawing, and stool and urine collection will be performed during visits at the beginning and end of each treatment period (T0 and T1). A 4 day-food diary record will be collected before visits T0, at the beginning of T0 and before T1.
Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, oxidized LDL, serum glucose and insulin, C-RP, Apolipoproteins, Isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis.
Safety assessments. Adverse events registration.
Statistical analyses. The differences between the two group will be evaluated with univariate and multivariate statistical methods. The medium before and after the intervention will be compared with the General Linear Model (ANOVA) for repeated measures or for paired data. Simple and multiple linear regressions will be performed to determine the relationships between independent variables; also we will run the t-test to evaluate differences in compliance detected in the types of supplementation. The results are expressed as mean +/- SEM and the differences will be considered significant when P <0.05.
Duration: Subjects will make three visits (visit T-1, beginning visit T0, and end of treatment period visit T1, week 8 from T0). The treatment duration is 8 weeks; a daily portion of about 90 g of biscuit is introduced.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: PreBIOil Dietary Supplement: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Measuring the Impact of Dietary Supplementation With New Baking Product PreBIOil on Gut Microbiota and Cholesterol Metabolism|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||January 2017|
Active Comparator: PREBIOIL TEST
Product tests prepared with olives flour, buckwheat flour, pea flour, chestnut flour, oil chemical leavening agents, salt, sucrose. Baked
Dietary Supplement: PreBIOil
A daily dose of about 90 gram will be given for 8 weeks
Placebo Comparator: CONTROL
Product control prepared with wheat flour, oil, chemical leavening agents, salt, sucrose. Baked
Dietary Supplement: Control
A daily dose of about 90 gram will be given for 8 weeks
- Faecal microbiota analysis [ Time Frame: 8 weeks ]Faecal microbiota analysis by FISH and 454 Roche pyrosequencing
- Cholesterol Metabolism [ Time Frame: 8 weeks ]Analysis of total, LDL, HDL cholesterol in plasma
- Triglycerides [ Time Frame: 8 weeks ]Analysis of plasma levels of triglycerides
- Apolipoproteins [ Time Frame: 8 weeks ]Apolipoprotein ApoA-I, ApoB, and Lp (a) analysis in plasma
- The anthropometric indices [ Time Frame: 8 weeks ]Analysis of the variation of the anthropometric indices
- The secondary metabolites of polyphenols in human biofluids [ Time Frame: 8 weeks ]Analysis of the polyphenols secondary metabolites in human biofluids
- Urine metabolites profile [ Time Frame: 8 weeks ]Measuring profiles of metabolites in plasma and urine assessed by analysis of mass spectrometry (MS)
- Plasma metabolites profiles [ Time Frame: 8 weeks ]Meauring the profiles of metabolites in plasma assessed by analysis of mass spectrometry (MS)
- Fasting insulin levels [ Time Frame: 8 weeks ]Analysis asting insulin levels
- Blood glucose [ Time Frame: 8 weeks ]Analysis of the blood glucose
- C-reactive protein (PRC) [ Time Frame: 8 weeks ]Analysis of C-reactive protein (PRC)
- Urinary isoprostane F2 [ Time Frame: 8 weeks ]Analysis of urinary isoprostane F2
- Oxidized LDL in plasma [ Time Frame: 8 weeks ]Analysi of oxidized LDL in plasma
- Faecal Bile Acids [ Time Frame: 8 weeks ]MS analysis of fecal bile acid concentrations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664428
|Casa di Cura Eremo|
|Arco, Trento, Italy, 38062|
|Centro Ricerca Innovazione Fondazione Edmund Mach|
|San Michele all'Adige, Trento, Italy, 38010|
|Study Director:||Roberto Viola, PhD||Fondazione Edmund Mach|