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CompletedNCT03956433PATHWAY-27Updated May 20, 2019

Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

An interventional study of Ready-made pancakes enriched with docosahexaenoic acid (DHA) and Ready-made pancakes enriched with beta-glucan (BG) in Metabolic Syndrome, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by University of Leeds · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Sep 2014, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Syndrome
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 35 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (actual)

Study arms

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

  • Dietary supplementReady-made pancakes enriched with docosahexaenoic acid (DHA)

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

  • Dietary supplementReady-made pancakes enriched with beta-glucan (BG)

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

  • Dietary supplementReady-made pancakes enriched with anthocyanins (AC)

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

  • Dietary supplementReady-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.

  • Dietary supplementReady-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.

06

What researchers measure

Primary outcomes

  1. Fasting triglyceride concentration

    Change in fasting triglyceride concentration between baseline and endpoint

    Time frame: Day 1 to Day 28

  2. Fasting HDL concentration

    Change in fasting HDL concentration between baseline and endpoint

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. Blood pressure

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

    Time frame: Day 1 to day 28

  2. Fasting blood glucose concentration

    Change in fasting blood glucose concentration between baseline and endpoint

    Time frame: Day 1 to day 28

  3. Waist circumference

    Change in waist circumference between baseline and endpoint

    Time frame: Day 1 to day 28

  4. Body mass index

    Change in body mass index between baseline and endpoint

    Time frame: Day 1 to day 28

07

Study locations

1 site
  • University of Leeds
    Leeds, West Yorkshire LS2 9JT, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03956433
Lead sponsor
University of Leeds
Collaborators
The Leeds Teaching Hospitals NHS Trust, AdWare Research Ltd., University of Bologna, European Union
Responsible party
Samantha Sutulic (Postdoctoral Research Fellow, University of Leeds) — Principal investigator
First posted
May 20, 2019
Start date
Sep 1, 2014
Primary completion
Jul 4, 2015
Completion
Jul 4, 2015
Last update
May 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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