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

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Ready-made pancakes enriched with docosahexaenoic acid (DHA)

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

Ready-made pancakes enriched with anthocyanins (AC)

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

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

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

University of Leeds

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Docosahexaenoic Acid enriched pancakes

Beta-glucan enriched pancakes

Anthocyanin enriched pancakes

DHA+BG enriched pancakes

DHA+AC enriched pancakes

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Fasting triglyceride concentration

Change in fasting triglyceride concentration between baseline and endpoint

Fasting HDL concentration

Change in fasting HDL concentration between baseline and endpoint

Secondary Outcome Measures

Blood pressure

Change in systolic and/or diastolic blood pressure between baseline and endpoint

Fasting blood glucose concentration

Change in fasting blood glucose concentration between baseline and endpoint

Waist circumference

Change in waist circumference between baseline and endpoint

Body mass index

Change in body mass index between baseline and endpoint

Full Information

NCT ID

NCT03956433

First Posted

January 26, 2018

Last Updated

May 17, 2019

Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust, AdWare Research Ltd., University of Bologna, European Union

1. Study Identification

Unique Protocol Identification Number

NCT03956433

Brief Title

Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

Acronym

PATHWAY-27

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2014 (Actual)

Primary Completion Date

July 4, 2015 (Actual)

Study Completion Date

July 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Leeds

Collaborators

The Leeds Teaching Hospitals NHS Trust, AdWare Research Ltd., University of Bologna, European Union

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Five treatment groups, no placebo.

Masking

ParticipantInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Docosahexaenoic Acid enriched pancakes

Arm Type

Experimental

Arm Description

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

Arm Title

Beta-glucan enriched pancakes

Arm Type

Experimental

Arm Description

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

Arm Title

Anthocyanin enriched pancakes

Arm Type

Experimental

Arm Description

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

Arm Title

DHA+BG enriched pancakes

Arm Type

Experimental

Arm 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.

Arm Title

DHA+AC enriched pancakes

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Ready-made pancakes enriched with docosahexaenoic acid (DHA)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Ready-made pancakes enriched with anthocyanins (AC)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Fasting triglyceride concentration

Description

Change in fasting triglyceride concentration between baseline and endpoint

Time Frame

Day 1 to Day 28

Title

Fasting HDL concentration

Description

Change in fasting HDL concentration between baseline and endpoint

Time Frame

Day 1 to Day 28

Secondary Outcome Measure Information:

Title

Blood pressure

Description

Change in systolic and/or diastolic blood pressure between baseline and endpoint

Time Frame

Day 1 to day 28

Title

Fasting blood glucose concentration

Description

Change in fasting blood glucose concentration between baseline and endpoint

Time Frame

Day 1 to day 28

Title

Waist circumference

Description

Change in waist circumference between baseline and endpoint

Time Frame

Day 1 to day 28

Title

Body mass index

Description

Change in body mass index between baseline and endpoint

Time Frame

Day 1 to day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: 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.

Facility Information:

Facility Name

University of Leeds

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS2 9JT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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