Clinical trial NCT03956433: Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: AdWare Research Ltd.
name: University of Bologna
name: European Union
First posted: 2019-05-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Five treatment groups, no placebo.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Fasting triglyceride concentration
timeFrame: Day 1 to Day 28
measure: Fasting HDL concentration
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Blood pressure
timeFrame: Day 1 to day 28
measure: Fasting blood glucose concentration
timeFrame: Day 1 to day 28
measure: Waist circumference
timeFrame: Day 1 to day 28
measure: Body mass index
timeFrame: Day 1 to day 28
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
References: