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| Name | Class |
|---|---|
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| AdWare Research Ltd. | UNKNOWN |
| University of Bologna | OTHER |
| European Union |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docosahexaenoic Acid enriched pancakes | Experimental | One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks. |
|
| Beta-glucan enriched pancakes | Experimental | One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks. |
|
| Anthocyanin enriched pancakes | Experimental | One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready-made pancakes enriched with docosahexaenoic acid (DHA) | Dietary Supplement | One portion of DHA-enriched pancakes will be eaten each day for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Change in systolic and/or diastolic blood pressure between baseline and endpoint | Day 1 to day 28 |
| Fasting blood glucose concentration | Change in fasting blood glucose concentration between baseline and endpoint |
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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:
Exclusion Criteria:
Participants are excluded if three or more clinical criteria for metabolic syndrome are met. Additionally, major exclusion criteria are:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leeds | Leeds | West Yorkshire | LS2 9JT | United Kingdom |
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| OTHER |
Five treatment groups, no placebo.
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Double-blind
|
| Ready-made pancakes enriched with beta-glucan (BG) | Dietary Supplement | One portion of BG-enriched pancakes will be eaten each day for 4 weeks. |
|
| Ready-made pancakes enriched with anthocyanins (AC) | Dietary Supplement | 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) | Dietary Supplement | 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) | Dietary Supplement | One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks. |
|
| Day 1 to day 28 |
| Waist circumference | Change in waist circumference between baseline and endpoint | Day 1 to day 28 |
| Body mass index | Change in body mass index between baseline and endpoint | Day 1 to day 28 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D047071 | beta-Glucans |
| D000872 | Anthocyanins |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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