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

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)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: 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)

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9JT
      • University of Leeds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docosahexaenoic Acid enriched pancakes; 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); One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.
Experimental: Beta-glucan enriched pancakes; 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); One portion of BG-enriched pancakes will be eaten each day for 4 weeks.
Experimental: Anthocyanin enriched pancakes; 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); One portion of AC-enriched pancakes will be eaten each day for 4 weeks.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: University of Bologna; The Leeds Teaching Hospitals NHS Trust; European Union; AdWare Research Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): July 4, 2015
• Study Completion (Actual): July 4, 2015

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: PW27_Pilot_Protocol_v1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No