Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry

Metabolic Syndrome Clinical Trial

— PATHWAY-27  

Official title:

Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEF) on Biochemical and Anthropometric Markers of Metabolic Syndrome (MS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02702713
• Other study ID #: 147/2015/U/Sper
• Status: Terminated
• Phase: N/A
• First received: February 18, 2016
• Last updated: November 29, 2017
• Start date: February 2016
• Est. completion date: October 20, 2017

Study information

• Verified date: November 2017
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being:

• fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR

• HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).

Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either:

• Dairy BEF + egg placebo + bakery placebo

• Egg BEF + dairy placebo + bakery placebo

• Bakery BEF + dairy placebo + egg placebo

• Dairy, egg and bakery placebo

Participants will be required to consume all three of the allocated products each day for 12 weeks.

Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks.

At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 325
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• subjects presenting with two to four diagnostic criteria for metabolic syndrome, at least one of them being elevated fasting triglycerides OR HDL-cholesterol =50 mg/mL in women, = 40mg/mL in men (with fasting triglycerides =110 mg/dL).

Exclusion Criteria:

• subjects with five clinical criteria for metabolic syndrome

• Regular drug therapy with impact on serum lipids;

• Diabetes (fasting glucose > 1.26 g/L, or anti-diabetic treatment);

• Celiac disease, lactose intolerance, allergy to milk or egg proteins;

• Antibiotic treatment within the last 3 months;

• Recent history of cancer or cancer treatment (less than 2 years);

• Active or recently diagnosed intestinal malabsorption;

• Diagnosis of organ failure

• Familial dyslipidemia (TG = 4.5 mmol/l or 400 mg/dl);

• Illegal drug use or chronic alcoholism or smoking;

• Intensive physical exercise (= 5 hour/week);

• Consumption of nutritional supplements containing DHA, BG or AC;

• History of allergy or intolerance to any components used in BEF;

• Women who are pregnant or lactating;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Dairy BEF
Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans
• Egg BEF
Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins
• Bakery BEF
Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins
• Bakery placebo
Bakery placebo: Biscuits without enrichment
• Dairy placebo
Dairy placebo: Milkshake powder without enrichment
• Egg placebo
Egg placebo: Frozen pancakes without enrichment

Locations

Country	Name	City	State
France	Centre de Récherche en Nutrition Humaine d'Auvergne	Clermont-Ferrand	Auvergne
Germany	Max Rubner-Institut	Karlsruhe	Baden-Württemberg
Italy	University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi	Bologna	BO
United Kingdom	University of Leeds	Leeds

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Centre de Recherche en Nutrition Humaine d'Auvergne, Max Rubner-Institut, University of Bologna, University of Leeds

Countries where clinical trial is conducted

France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triglycerides blood levels (mg/dl)	Change from baseline in triglycerides blood levels after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Primary	HDL-cholesterol blood levels (mg/dl)	Change from baseline in HDL-cholesterol blood levels after 12 weeks of consumption of foods	Baseline and 12 weeks
Secondary	Blood glucose (mg/dl).	Change from baseline in blood glucose levels after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Blood pressure (mmHg)	Change from baseline in blood pressure after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Waist circumference (cm).	Change from baseline in waist circumference after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Urinary food metabolite levels (parts per millions).	Changes from baseline in urinary food metabolite levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Fecal microbiota composition (analysis of principal coordinates - PCOA)	Changes in fecal bacterial composition and diversity will be determined at baseline and after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS. The predominant microbial community and specific functional groups will be characterized by next-generation sequencing (NGS) of the 16S rDNA gene. The interindividual differences in the composition of the intestinal microbiota (beta-diversity) will be evaluated with the analysis of principal coordinates (PCOA). Appropriate statistical analysis will be performed to evaluate significant differences in the relative abundance of the microbial groups of intestinal microbiota between different groups of subjects.	Baseline and 12 weeks
Secondary	Fecal Short Chain Fatty Acids (parts per million).	Change from baseline in production/uptake in the stool of Short Chain Fatty Acids, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Dna methylation levels (%).	To test whether lymphocytes may be useful as a surrogate for adipose tissue to detect changes in DNA methylation and gene expression, genome-wide methylation differences will be performed in parallel in lymphocytes and fat cells from baseline and after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS. Expression of affected genes will be evaluated by qRT-PCR.	Baseline and 12 weeks
Secondary	Serum Hemoglobin A1c (HbA1c) levels (%)	Change from baseline in HbA1c levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Homeostasis Model Assessment (HOMA) Index levels.	Change from baseline in Homeostasis Model Assessment Index levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks
Secondary	Fecal metabolite levels (parts per millions).	Change from baseline in food metabolite levels in the stools after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.	Baseline and 12 weeks

External Links

•   Pathway-27 website