Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEFs) on Biochemical and Anthropometric Markers of the Metabolic Syndrome in Human Volunteers (a Pilot Study)

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)
* Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)
* Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)
* Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)
* Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Five treatment groups, no placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docosahexaenoic Acid enriched pancakes<br>One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks. | Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)<br>* One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.<br>|
| Experimental: Beta-glucan enriched pancakes<br>One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks. | Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)<br>* One portion of BG-enriched pancakes will be eaten each day for 4 weeks.<br>|
| Experimental: Anthocyanin enriched pancakes<br>One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks. | Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)<br>* One portion of AC-enriched pancakes will be eaten each day for 4 weeks.<br>|
| Experimental: DHA+BG enriched pancakes<br>One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 3 g beta-glucan (BG) to be consumed daily for 4 weeks. | Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)<br>* One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.<br>|
| Experimental: DHA+AC enriched pancakes<br>One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 320 mg anthocyanins (AC) to be consumed daily for 4 weeks. | Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)<br>* One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting triglyceride concentration | Change in fasting triglyceride concentration between baseline and endpoint | Day 1 to Day 28 | 
| Fasting HDL concentration | Change in fasting HDL concentration between baseline and endpoint | Day 1 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change in systolic and/or diastolic blood pressure between baseline and endpoint | Day 1 to day 28 | 
| Fasting blood glucose concentration | Change in fasting blood glucose concentration between baseline and endpoint | Day 1 to day 28 | 
| Waist circumference | Change in waist circumference between baseline and endpoint | Day 1 to day 28 | 
| Body mass index | Change in body mass index between baseline and endpoint | Day 1 to day 28 |