Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

NCT ID: NCT03956433

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-01
• Study Completion Date: 2015-07-04

Brief Summary

This pilot study will investigate the enrichment type, in pancakes, most effective at improving markers of metabolic syndrome. Ready-made pancakes enriched with either docosahexaenoic acid (DHA), beta-glucan (BG) or anthocyanins (AC), alone or in combination of DHA+BG or DHA+AC, will be consumed for 4 weeks.

Detailed Description

There is scientific evidence to support health claims that docosahexaenoic acid (DHA), an omega-3 fatty acid, and beta-glucan (BG), a soluble plant fibre, can help to maintain healthy cholesterol and triglyceride levels. It is also reported that anthocyanins (AC), colour pigments found in many dietary plants, can lower concentrations of low-density lipoprotein (LDL) cholesterol and increase high-density lipoprotein (HDL) cholesterol in dyslipidemic adults. Research studies often focus on bioactives administered as supplements, this study will also investigate the effectiveness of the food matrix. The project addresses the exploitation of bioactive compounds extracted from natural food sources that when added as ingredients to foods and consumed within the common diet, could significantly benefit human health and wellbeing.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Docosahexaenoic Acid enriched pancakes

One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks.

Group Type: EXPERIMENTAL

Ready-made pancakes enriched with docosahexaenoic acid (DHA)

Intervention Type: DIETARY_SUPPLEMENT

One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.

Beta-glucan enriched pancakes

One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks.

Group Type: EXPERIMENTAL

Ready-made pancakes enriched with beta-glucan (BG)

Intervention Type: DIETARY_SUPPLEMENT

One portion of BG-enriched pancakes will be eaten each day for 4 weeks.

Anthocyanin enriched pancakes

One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.

Group Type: EXPERIMENTAL

Ready-made pancakes enriched with anthocyanins (AC)

Intervention Type: DIETARY_SUPPLEMENT

One portion of AC-enriched pancakes will be eaten each day for 4 weeks.

DHA+BG enriched pancakes

One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 3 g beta-glucan (BG) to be consumed daily for 4 weeks.

Group Type: EXPERIMENTAL

Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)

Intervention Type: DIETARY_SUPPLEMENT

One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.

DHA+AC enriched pancakes

One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.

Group Type: EXPERIMENTAL

Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)

Intervention Type: DIETARY_SUPPLEMENT

One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.

Interventions

Ready-made pancakes enriched with docosahexaenoic acid (DHA)

One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Ready-made pancakes enriched with beta-glucan (BG)

One portion of BG-enriched pancakes will be eaten each day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Ready-made pancakes enriched with anthocyanins (AC)

One portion of AC-enriched pancakes will be eaten each day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)

One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)

One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Subjects will be eligible to the pilot study if they present with two to four of the criteria for metabolic syndrome (MetS), at least one of them being alteration of fasting triglycerides or HDL-C cholesterol. MetS is defined when three of the following criteria are met:

• elevated waist circumference (men ≥ 102 cm; women ≥ 88 cm)
• elevated fasting triglycerides (≥ 150 mg/dL)
• reduced fasting HDL-cholesterol (men ≤ 40 mg/dL; women ≤ 50 mg/dL)
• elevated blood pressure (systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg) or hypotensive treatment
• elevated fasting glucose (≥ 110 mg/dL)

Exclusion Criteria

• regular drug therapy with impact on serum lipids;
• diabetes (fasting glucose > 1.26 g/L, or anti-diabetic treatment);
• recent history of cancer or cancer treatment (less than 2 years);
• active or recently diagnosed intestinal malabsorption or disorders associated with malabsorption: Crohn's disease, short bowel syndrome, Pancreatic insufficiency , cystic fibrosis, Tropical Sprue, whipple's disease, chronic pancreatitis, gastrojejunostomy, surgical treatments for obesity, cholestasis, biliary atresia, parasite infections, HIV/AIDS
• familial dyslipidemia;
• use of medication known to cause malabsorption: tetracycline, cholestyramine, thiazide diuretics, aluminum/magnesium hydroxide, colchicine, neomycin, methotrexate, methyldopa, and allopurinol, and laxatives
• illegal drug use, chronic alcoholism or active 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 BEFs, celiac disease, lactose intolerance, allergy to milk or egg proteins;
• institutionalised patients, those who lack autonomy to consent or are unable to meet all examinations;
• women who are pregnant, lactating or actively trying to conceive;
• participation in other clinical trials that may impact on outcome;
• subjects deprived of their liberty by judicial or administrative decision.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

AdWare Research Ltd.

UNKNOWN

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

European Union

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Samantha Sutulic

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Leeds

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

PW27_Pilot_Protocol_v1.2

Identifier Type: -

Identifier Source: org_study_id