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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Leeds
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Fasting HDL concentration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Outcomes
Primary Outcomes
Fasting HDL concentration
Time Frame: Day 1 to Day 28
Change in fasting HDL concentration between baseline and endpoint
Fasting triglyceride concentration
Time Frame: Day 1 to Day 28
Change in fasting triglyceride concentration between baseline and endpoint
Secondary Outcomes
- Waist circumference(Day 1 to day 28)
- Blood pressure(Day 1 to day 28)
- Fasting blood glucose concentration(Day 1 to day 28)
- Body mass index(Day 1 to day 28)
Investigators
Samantha Sutulic
Postdoctoral Research Fellow
University of Leeds