Metabolic SyndromePATHWAY-27NCT03956433

Effect of Bioactive Enriched Food on Markers of Metabolic Syndrome

A study testing Ready-made pancakes enriched with docosahexaenoic acid (DHA), Ready-made pancakes enriched with beta-glucan (BG) and Ready-made pancakes enriched with anthocyanins (AC) in people with Metabolic Syndrome, run by University of Leeds at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Metabolic Syndrome
What is being tested?: Ready-made pancakes enriched with docosahexaenoic acid (DHA), Ready-made pancakes enriched with beta-glucan (BG) and Ready-made pancakes enriched with anthocyanins (AC)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2014to 4 Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Leeds
Leeds, West Yorkshire, LS2 9JT

Other trials in United Kingdom

About this study

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)

Read the 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.

Conditions: Metabolic Syndrome
Being tested: Ready-made pancakes enriched with docosahexaenoic acid (DHA), Ready-made pancakes enriched with beta-glucan (BG), Ready-made pancakes enriched with anthocyanins (AC), Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG), Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ready-made pancakes enriched with docosahexaenoic acid (DHA)Dietary supplement
One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.
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.

Study groups in NCT03956433
Study group	Role	What they receive
Docosahexaenoic Acid enriched pancakes	Experimental	One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks. Receives: Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)
Beta-glucan enriched pancakes	Experimental	One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks. Receives: Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)
Anthocyanin enriched pancakes	Experimental	One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks. Receives: Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)
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. Receives: Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)
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. Receives: Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting triglyceride concentration
Change in fasting triglyceride concentration between baseline and endpoint
Measured: Day 1 to Day 28
Fasting HDL concentration
Change in fasting HDL concentration between baseline and endpoint
Measured: Day 1 to Day 28

Secondary outcomes (4)

Blood pressure
Change in systolic and/or diastolic blood pressure between baseline and endpoint
Measured: Day 1 to day 28
Fasting blood glucose concentration
Change in fasting blood glucose concentration between baseline and endpoint
Measured: Day 1 to day 28
Waist circumference
Change in waist circumference between baseline and endpoint
Measured: Day 1 to day 28
Body mass index
Change in body mass index between baseline and endpoint
Measured: Day 1 to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20144 Jul 2015

First posted20 May 2019
Study start1 Sep 2014
Primary completion4 Jul 2015
Study completion4 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Five treatment groups, no placebo.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03956433
Sponsor's protocol ID: PW27_Pilot_Protocol_v1.2
Acronym: PATHWAY-27
Status last verified: May 2019
First submitted: 26 Jan 2018
Last updated: 20 May 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03956433
Acronym / sponsor ID: PATHWAY-27 / PW27_Pilot_Protocol_v1.2
Conditions: Metabolic Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of LeedsUniversity, hospital or other
Collaborators: The Leeds Teaching Hospitals NHS Trust, AdWare Research Ltd., University of Bologna, European Union
Study start: 1 Sep 2014 (actual)
Primary completion: 4 Jul 2015 (actual)
Study completion: 4 Jul 2015 (actual)
First posted: 20 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: Five treatment groups, no placebo.

Arm	Type	Receives
Docosahexaenoic Acid enriched pancakes	Experimental	Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid (DHA)One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) to be consumed daily for 4 weeks.
Beta-glucan enriched pancakes	Experimental	Dietary Supplement: Ready-made pancakes enriched with beta-glucan (BG)One portion of pancakes enriched with 3 g beta-glucan (BG) to be consumed daily for 4 weeks.
Anthocyanin enriched pancakes	Experimental	Dietary Supplement: Ready-made pancakes enriched with anthocyanins (AC)One portion of pancakes enriched with 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.
DHA+BG enriched pancakes	Experimental	Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)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	Dietary Supplement: Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)One portion of pancakes enriched with 250 mg docosahexaenoic acid (DHA) plus 320 mg anthocyanins (AC) to be consumed daily for 4 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ready-made pancakes enriched with docosahexaenoic acid (DHA)One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.	Dietary supplement	Docosahexaenoic Acid enriched pancakes
Ready-made pancakes enriched with beta-glucan (BG)One portion of BG-enriched pancakes will be eaten each day for 4 weeks.	Dietary supplement	Beta-glucan enriched pancakes
Ready-made pancakes enriched with anthocyanins (AC)One portion of AC-enriched pancakes will be eaten each day for 4 weeks.	Dietary supplement	Anthocyanin enriched pancakes
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.	Dietary supplement	DHA+BG enriched pancakes
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.	Dietary supplement	DHA+AC enriched pancakes

Primary outcome

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

4 secondary outcomes

Blood pressure
Time frame: Day 1 to day 28
Fasting blood glucose concentration
Time frame: Day 1 to day 28
Waist circumference
Time frame: Day 1 to day 28
Body mass index
Time frame: Day 1 to day 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Individual participant dataSharing planned: No

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting triglyceride concentration (time frame: Day 1 to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03956433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.