Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome (PATHWAY-27)

University of Leeds

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC); Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG); Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA); Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG); Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03956433

PW27_Pilot_Protocol_v1.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Participants are excluded if three or more clinical criteria for metabolic syndrome are met. Additionally, major exclusion criteria are:

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 5 patient groups

Docosahexaenoic Acid enriched pancakes

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)

Beta-glucan enriched pancakes

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)

Anthocyanin enriched pancakes

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)

DHA+BG enriched pancakes

Experimental group

Description:

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

Treatment:

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

DHA+AC enriched pancakes

Experimental group

Description:

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

Treatment:

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