NCT02664428

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. 1.fecal microbiota profile;
  2. 2.Plasma cholesterol LDL, total, total LDL and HDL ratio;
  3. 3.plasma triglycerides;
  4. 4.Apolipoprotein ApoA-I, ApoB, and Lp.
  5. 5.anthropometric indices;
  6. 6.secondary metabolites of polyphenols in human biofluids;
  7. 7.mass spectrometry plasma and urine metabolite profile;
  8. 8.blood glucose and fasting insulin levels; 5,6) C-reactive protein (PRC or hsPRC);

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 16, 2016

Last Update Submit

January 11, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Faecal microbiota analysis

    Faecal microbiota analysis by FISH and 454 Roche pyrosequencing

    8 weeks

Secondary Outcomes (3)

  • Cholesterol Metabolism

    8 weeks

  • Triglycerides

    8 weeks

  • Apolipoproteins

    8 weeks

Other Outcomes (10)

  • The anthropometric indices

    8 weeks

  • The secondary metabolites of polyphenols in human biofluids

    8 weeks

  • Urine metabolites profile

    8 weeks

  • +7 more other outcomes

Study Arms (2)

PREBIOIL TEST

ACTIVE COMPARATOR

Product tests prepared with olives flour, buckwheat flour, pea flour, chestnut flour, oil chemical leavening agents, salt, sucrose. Baked

Dietary Supplement: PreBIOil

CONTROL

PLACEBO COMPARATOR

Product control prepared with wheat flour, oil, chemical leavening agents, salt, sucrose. Baked

Dietary Supplement: Control

Interventions

PreBIOilDIETARY_SUPPLEMENT

A daily dose of about 90 gram will be given for 8 weeks

PREBIOIL TEST
ControlDIETARY_SUPPLEMENT

A daily dose of about 90 gram will be given for 8 weeks

CONTROL

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Casa di Cura Eremo

Arco, Trento, 38062, Italy

Location

Centro Ricerca Innovazione Fondazione Edmund Mach

San Michele all'Adige, Trento, 38010, Italy

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Roberto Viola, PhD

    Fondazione Edmund Mach

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 16, 2016

First Posted

January 27, 2016

Study Start

November 1, 2015

Primary Completion

August 1, 2016

Study Completion

January 1, 2017

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

IT(2)