Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index

NCT02067026 | Completed

• 1 other identifier: CFIS-13-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Study hypothesis Aleurone-rich food supplementation modifies cardiovascular and metabolic risk profiles and gut microbiota in subjects with high BMI Primary objectives of the trial are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fasting homocysteine levels; (2) human biofluid primary metabolites; (3) human biofluid secondary (microbiota-derived) metabolites; (4) fecal bile acid and fecal sterol concentrations. Secondary objectives are to evaluate whether wheat Aleurone-rich food supplementation modifies (1) fecal microbiota, (2) plasma and urine MS based metabolite profiling; (3) total cholesterol, triglycerides, LDL- and HDL-cholesterol levels; (4) serum glucose and insulin levels; (5) anthropometric indices; (6) urinary isoprostane levels; (7) markers of intestinal permeability in plasma; (8) inflammation Study Design Placebo-controlled, randomized, double-blind parallel trial Criteria for Enrollment Inclusion criteria: Aged 18-65 years; BMI \>27 kg/m\^2. Good General health. Exclusion criteria: Fasting blood glucose \>300 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 After a run-in phase of two weeks, participants will be randomized to receive supplementation with either wheat Aleurone-rich food (27 g Aleurone/day) or placebo for 4 weeks in a double-blind manner. Clinical visit, clinical tests, and blood drawing will be performed after an overnight fasting at the start of the run-in phase (visit T-1) at U.O.S. di Dietetica e Nutrizione Clinica, St Chiara, Trento. 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) at U.O.S. di Dietetica e Nutrizione Clinica, St chiara, Trento. A 4 day-food diary record will be collected before visits T0 and T1. Efficacy Assessments Arterial BP; BMI; ratio of waist to hip circumference; food questionnaires; blood sample analysis (total cholesterol, triglycerides, HDL and LDL cholesterol, serum glucose and insulin, C-RP, plasma LPS, LPS specific IgG, CD14, LPS-binding protein); urinary isoprostane; urinary and plasma metabolite profiling; fecal microbiota analysis. Safety Assessments. Adverse events. Statistical analyses. Post-intervention data will be compared by ANOVA using the General Linear Model with baseline as a covariate. Data with a skewed distribution will be log transformed before analyses. Simple and multiple linear regression will be used to determine relationships between variables and independent t-tests performed to evaluate differences in reported compliance between groups. Results will be expressed as mean +/- SEM and differences will be considered significant at P \< 0.05.. Duration of Dosing. Subjects will make three visits during the study (start of run-in phase - visit T-1-, beginning - visit T0, week 2 - and end of treatment period - visit T1, week 6). Duration of the treatment period is four weeks; a daily Aleurone consumption of 27 g is targeted.

Conditions

Overweight; Healthy Subjects

Keywords

overweight

Outcome Measures

Primary Outcomes (1)

• change in total plasma homocysteine (tHcy)

  Change in total plasma homocysteine between timepoints week 2 (baseline) and week 6 (end of dietary supplementation).

  2 and 6 weeks

Secondary Outcomes (4)

• metabolomics

  2 and 6 weeks

• Secondary microbial metabolites in blood, urine and feces

  2 and 6 weeks

• faecal microbiota analysis

  2 and 6 weeks

• fecal bile acid and fecal sterol concentrations

  2 and 6 weeks

Other Outcomes (1)

• other metabolites and inflammatory markers

  2 and 6 weeks, corresponding to baseline and end of treatment

Study Arms (2)

Aleurone supplementation

EXPERIMENTAL

The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Aleurone/day. One bread bun (35 g) contains 4.8 g Aleurone; one biscuit (15 g) contains 4 g Aleurone; 36 g of RTE cereals contain 9 g Aleurone.

Dietary Supplement: Aleurone

Hemicellulose supplementation

PLACEBO COMPARATOR

The study supplementation will be introduced in the daily diet according to the participant preference to a total of 27g of Hemicellulose/day. One bread bun (35 g) contains 4.8 g Hemicellulose; one biscuit (15 g) contains 4 g Hemicellulose; 36 g of RTE cereals contain 9 g Hemicellulose. Placebo products contain the same levels of cellulose in place of aleurone's dietary fiber content.

Dietary Supplement: Placebo

Interventions

Aleurone DIETARY_SUPPLEMENT

Also known as: Cargill R&D Centre Europe ASP-01 Aleurone

Aleurone supplementation

Placebo DIETARY_SUPPLEMENT

Also known as: Placebo hemicellulose

Hemicellulose supplementation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI above 30 kg/m\^2

You may not qualify if:

• fasting blood glucose \>300 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;
• 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.

Sponsors & Collaborators

• Fondazione Edmund Mach: lead
• Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium: collaborator
• Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento: collaborator

Study Sites (2)

Fondazione Edmund Mach -Centro Ricerca ed Innovazione

San Michele all'Adige, TN, 38010, Italy

Location

Unità di Dietetica e Nutrizione Clinica, Ospedale S. Chiara, Via Orsi 1

Trento, TN, 38100, Italy

Location

Related Publications (1)

• Fava F, Ulaszewska MM, Scholz M, Stanstrup J, Nissen L, Mattivi F, Vermeiren J, Bosscher D, Pedrolli C, Tuohy KM. Impact of wheat aleurone on biomarkers of cardiovascular disease, gut microbiota and metabolites in adults with high body mass index: a double-blind, placebo-controlled, randomized clinical trial. Eur J Nutr. 2022 Aug;61(5):2651-2671. doi: 10.1007/s00394-022-02836-9. Epub 2022 Mar 5.

  PMID: 35247098 DERIVED

MeSH Terms

Conditions

Overweight

Interventions

aleurone

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kieran M Tuohy, PhD

  Fondazione Edmund Mach

  PRINCIPAL INVESTIGATOR

• Carlo Pedrolli, MD

  Azienda Sanitaria per i Servizi Sanitari della Provincia Autonoma di Trento

  STUDY DIRECTOR

• Douwina Bosscher, PhD

  Cargill FIS/ Global Food Research

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 20, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

IT (2)