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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
Sponsor:
Collaborators:
Casa di Cura Eremo di Arco (TN) Italy
OlioCRU Consorzio srl Arco (TN) Italy
Information provided by (Responsible Party):
Kieran Tuohy, Fondazione Edmund Mach

Brief Summary:

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:

  1. fecal microbiota profile;
  2. Plasma cholesterol LDL, total, total LDL and HDL ratio;
  3. plasma triglycerides;
  4. Apolipoprotein ApoA-I, ApoB, and Lp.

Secondary objectives of the study are:

  1. anthropometric indices;
  2. secondary metabolites of polyphenols in human biofluids;
  3. mass spectrometry plasma and urine metabolite profile;
  4. 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Faecal microbiota analysis [ Time Frame: 8 weeks ]
    Faecal microbiota analysis by FISH and 454 Roche pyrosequencing


Secondary Outcome Measures :
  1. Cholesterol Metabolism [ Time Frame: 8 weeks ]
    Analysis of total, LDL, HDL cholesterol in plasma

  2. Triglycerides [ Time Frame: 8 weeks ]
    Analysis of plasma levels of triglycerides

  3. Apolipoproteins [ Time Frame: 8 weeks ]
    Apolipoprotein ApoA-I, ApoB, and Lp (a) analysis in plasma


Other Outcome Measures:
  1. The anthropometric indices [ Time Frame: 8 weeks ]
    Analysis of the variation of the anthropometric indices

  2. The secondary metabolites of polyphenols in human biofluids [ Time Frame: 8 weeks ]
    Analysis of the polyphenols secondary metabolites in human biofluids

  3. Urine metabolites profile [ Time Frame: 8 weeks ]
    Measuring profiles of metabolites in plasma and urine assessed by analysis of mass spectrometry (MS)

  4. Plasma metabolites profiles [ Time Frame: 8 weeks ]
    Meauring the profiles of metabolites in plasma assessed by analysis of mass spectrometry (MS)

  5. Fasting insulin levels [ Time Frame: 8 weeks ]
    Analysis asting insulin levels

  6. Blood glucose [ Time Frame: 8 weeks ]
    Analysis of the blood glucose

  7. C-reactive protein (PRC) [ Time Frame: 8 weeks ]
    Analysis of C-reactive protein (PRC)

  8. Urinary isoprostane F2 [ Time Frame: 8 weeks ]
    Analysis of urinary isoprostane F2

  9. Oxidized LDL in plasma [ Time Frame: 8 weeks ]
    Analysi of oxidized LDL in plasma

  10. Faecal Bile Acids [ Time Frame: 8 weeks ]
    MS analysis of fecal bile acid concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male and female;
  • age between 30 and 65 years;
  • with BMI (body mass index, BMI) of between 20 and 29.9 kg/m2,
  • total plasma cholesterol in the range 180-240 mg/dl.

Exclusion Criteria:

Subjects will be excluded from participation in the study if they meet one of the following exclusion criteria:

  • fasting glucose> 140 mg/dl;
  • triglycerides> 500 mg/dl;
  • uncontrolled hypertension (BP >160/100 mm Hg under antihypertensive therapy); cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, unstable angina pectoris, stoke, peripheral arterial disease);
  • hypo or hyperthyroidism;
  • acute inflammatory diseases;
  • serious gastrointestinal disease;
  • hypo- or hyperthyroidism;
  • acute inflammatory diseases;
  • severe gastrointestinal diseases;
  • heart, liver, renal or pulmonary failure or other life threatening disease with prognosis <5 years;
  • chronic use of systemic corticosteroids, anti-coagulants, anti-inflammatory, or lipid lowering and anti-diabetics drugs;
  • treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels or fecal microbiota (specifically, antibiotics);
  • food intolerances;
  • alcohol intake >5 drinks per day or use of narcotic substances;
  • use of antioxidant vitamin or mineral supplements;
  • special diet;
  • pregnancy;
  • smoking.

Information from the National Library of Medicine

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


Locations
Italy
Casa di Cura Eremo
Arco, Trento, Italy, 38062
Centro Ricerca Innovazione Fondazione Edmund Mach
San Michele all'Adige, Trento, Italy, 38010
Sponsors and Collaborators
Fondazione Edmund Mach
Casa di Cura Eremo di Arco (TN) Italy
OlioCRU Consorzio srl Arco (TN) Italy
Investigators
Study Director: Roberto Viola, PhD Fondazione Edmund Mach

Responsible Party: Kieran Tuohy, Dr, Fondazione Edmund Mach
ClinicalTrials.gov Identifier: NCT02664428     History of Changes
Other Study ID Numbers: PreBIOil 2
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases