Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956433
• Other study ID #: PW27_Pilot_Protocol_v1.2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: July 4, 2015

Study information

• Verified date: May 2019
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 4, 2015
• Est. primary completion date: July 4, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Ready-made pancakes enriched with docosahexaenoic acid (DHA)
One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.
• Ready-made pancakes enriched with beta-glucan (BG)
One portion of BG-enriched pancakes will be eaten each day for 4 weeks.
• Ready-made pancakes enriched with anthocyanins (AC)
One portion of AC-enriched pancakes will be eaten each day for 4 weeks.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Leeds	Leeds	West Yorkshire

Sponsors (5)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting triglyceride concentration	Change in fasting triglyceride concentration between baseline and endpoint	Day 1 to Day 28
Primary	Fasting HDL concentration	Change in fasting HDL concentration between baseline and endpoint	Day 1 to Day 28
Secondary	Blood pressure	Change in systolic and/or diastolic blood pressure between baseline and endpoint	Day 1 to day 28
Secondary	Fasting blood glucose concentration	Change in fasting blood glucose concentration between baseline and endpoint	Day 1 to day 28
Secondary	Waist circumference	Change in waist circumference between baseline and endpoint	Day 1 to day 28
Secondary	Body mass index	Change in body mass index between baseline and endpoint	Day 1 to day 28