Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

NCT03956433 | Completed

• 1 other identifier: PW27_Pilot_Protocol_v1.2
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Blood pressure

  Day 1 to day 28

• Fasting blood glucose concentration

  Day 1 to day 28

• Waist circumference

  Day 1 to day 28

• Body mass index

  Day 1 to day 28

Study Arms (5)

Docosahexaenoic Acid enriched pancakes

EXPERIMENTAL

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)

Beta-glucan enriched pancakes

EXPERIMENTAL

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)

Anthocyanin enriched pancakes

EXPERIMENTAL

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)

DHA+BG enriched pancakes

EXPERIMENTAL

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)

DHA+AC enriched pancakes

EXPERIMENTAL

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

Ready-made pancakes enriched with docosahexaenoic acid (DHA) DIETARY_SUPPLEMENT

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

Docosahexaenoic Acid enriched pancakes

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

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

Beta-glucan enriched pancakes

Ready-made pancakes enriched with anthocyanins (AC) DIETARY_SUPPLEMENT

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

Anthocyanin enriched pancakes

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

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

DHA+BG enriched pancakes

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

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

DHA+AC enriched pancakes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• AdWare Research Ltd.: collaborator
• University of Bologna: collaborator
• European Union: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Docosahexaenoic Acids; beta-Glucans; Anthocyanins

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Glucans; Polysaccharides; Carbohydrates; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Model Details: Five treatment groups, no placebo.

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: May 20, 2019
• Study Start: September 1, 2014
• Primary Completion: July 4, 2015
• Study Completion: July 4, 2015
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)