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出境医 / 临床实验 / Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome (PATHWAY-27)
Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome (PATHWAY-27)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Syndrome | Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA) Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG) Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC) Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG) Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC) | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Five treatment groups, no placebo. |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Double-blind |
| Primary Purpose: | Basic Science |
| 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) |
| Actual Study Start Date : | September 1, 2014 |
| Actual Primary Completion Date : | July 4, 2015 |
| Actual Study Completion Date : | July 4, 2015 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Docosahexaenoic Acid enriched pancakes
One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks.
|
Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)
One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.
|
|
Experimental: Beta-glucan enriched pancakes
One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks.
|
Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)
One portion of BG-enriched pancakes will be eaten each day for 4 weeks.
|
|
Experimental: Anthocyanin enriched pancakes
One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.
|
Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)
One portion of AC-enriched pancakes will be eaten each day for 4 weeks.
|
|
Experimental: DHA+BG enriched pancakes
One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 3 g beta-glucan (BG) to be consumed daily for 4 weeks.
|
Dietary Supplement: 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.
|
|
Experimental: DHA+AC enriched pancakes
One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.
|
Dietary Supplement: 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.
|
Outcome Measures
Primary Outcome Measures :
- Fasting triglyceride concentration [ Time Frame: Day 1 to Day 28 ]Change in fasting triglyceride concentration between baseline and endpoint
- Fasting HDL concentration [ Time Frame: Day 1 to Day 28 ]Change in fasting HDL concentration between baseline and endpoint
Secondary Outcome Measures :
- Blood pressure [ Time Frame: Day 1 to day 28 ]Change in systolic and/or diastolic blood pressure between baseline and endpoint
- Fasting blood glucose concentration [ Time Frame: Day 1 to day 28 ]Change in fasting blood glucose concentration between baseline and endpoint
- Waist circumference [ Time Frame: Day 1 to day 28 ]Change in waist circumference between baseline and endpoint
- Body mass index [ Time Frame: Day 1 to day 28 ]Change in body mass index between baseline and endpoint
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Locations
| United Kingdom | |
| University of Leeds | |
| Leeds, West Yorkshire, United Kingdom, LS2 9JT | |
Sponsors and Collaborators
University of Leeds
The Leeds Teaching Hospitals NHS Trust
AdWare Research Ltd.
University of Bologna
European Union
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 26, 2018 | ||||
| First Posted Date ICMJE | May 20, 2019 | ||||
| Last Update Posted Date | May 20, 2019 | ||||
| Actual Study Start Date ICMJE | September 1, 2014 | ||||
| Actual Primary Completion Date | July 4, 2015 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome | ||||
| Official Title ICMJE | 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) | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Five treatment groups, no placebo. Masking: Double (Participant, Investigator)Masking Description: Double-blind Primary Purpose: Basic Science
|
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| Condition ICMJE | Metabolic Syndrome | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
35 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | July 4, 2015 | ||||
| Actual Primary Completion Date | July 4, 2015 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03956433 | ||||
| Other Study ID Numbers ICMJE | PW27_Pilot_Protocol_v1.2 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Samantha Sutulic, University of Leeds | ||||
| Study Sponsor ICMJE | University of Leeds | ||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Leeds | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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