Metabolic Syndrome
Conditions
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.
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.
Sponsors
The Leeds Teaching Hospitals NHS Trust
AdWare Research Ltd.
University of Bologna
European Union
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Five treatment groups, no placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting triglyceride concentration | Day 1 to Day 28 | Change in fasting triglyceride concentration between baseline and endpoint |
| Fasting HDL concentration | Day 1 to Day 28 | Change in fasting HDL concentration between baseline and endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Day 1 to day 28 | Change in systolic and/or diastolic blood pressure between baseline and endpoint |
| Fasting blood glucose concentration | Day 1 to day 28 | Change in fasting blood glucose concentration between baseline and endpoint |
| Waist circumference | Day 1 to day 28 | Change in waist circumference between baseline and endpoint |
| Body mass index | Day 1 to day 28 | Change in body mass index between baseline and endpoint |
Countries
United Kingdom
Outcome results
None listed