Healthy VolunteersNCT03118583
Effects of a Dietary Supplement on Lipoprotein Lipids and Inflammatory Markers
A study testing 300 mg/day of dietary supplement containing carrageenan in people with Healthy Volunteers, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The goal of this study is to assess the effects of a dietary supplement on fasting lipoprotein lipids and a marker of inflammation in men and women with levels of low-density lipoprotein cholesterol above desirable levels. Read more about this study
- Who is it for?
- Ages 25 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 300 mg/day of dietary supplement containing carrageenan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 31 Jan 2018
- 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 25 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 18.5-34.9 kg/m2
- Judged to be in good health on basis of medical history and screening laboratory tests
- Fasting LDL-C ≥115 mg/dL and <190 mg/dL
Who cannot join
- Abnormal laboratory test results of clinical significance (e.g., TG ≥400 mg/dL, blood glucose ≥126 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5X the upper limit of normal)
- Atherosclerotic cardiovascular disease or other evidence of atherosclerotic cardiovascular disease (myocardial infarction or other acute coronary syndrome, coronary or other revascularization procedure, transient ischemic attack, ischemic stroke, atherosclerotic peripheral arterial disease or other documented atherosclerotic diseases)
- Recent major trauma or surgical event
- History or presence of clinically important pulmonary, endocrine, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders
- History or current gastrointestinal disorder with the potential to disrupt normal digestion and absorption
- Known allergy, sensitivity, or intolerance to any ingredients in the study product
Show all 16Show fewer
- Uncontrolled hypertension
- Recent history of cancer (except non-melanoma skin cancer)
- Recent weight change ≥4.5 kg
- History of diagnosed eating disorder
- Extreme dietary habits
- Current or recent history of, or strong potential for, drug or alcohol abuse
- Recent use of medications intended to alter the lipid profile, (e.g., statins, bile acid sequestrants, cholesterol absorption inhibitor, fibrates, niacin [drug form] or omega-3 fatty acid drugs), weight-loss drugs or programs, systemic corticosteroids, anticoagulants, or unstable use of any antihypertensive medication
- Recent use of foods or dietary supplements with potential to influence lipid metabolism (e.g., omega-3 fatty acid supplements or fortified foods, sterol/stanol products, red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues at doses >400 mg/d) and viscous dietary fiber supplements (e.g., psyllium, beta-glucan, methylceullylose and/or carrageenan)
- Recent use of antibiotics
- Pregnant, planning to be pregnant during the study period or lactating females or women of childbearing potential unwilling to commit to use of a medically approved form of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Pilot Trial to Assess the Effects of a Dietary Supplement on Fasting Lipoprotein Lipids and a Marker of Inflammation in Men and Women With Above-desirable Levels of Low-density Lipoprotein Cholesterol
The goal of this study is to assess the effects of a dietary supplement on fasting lipoprotein lipids and a marker of inflammation in men and women with levels of low-density lipoprotein cholesterol above desirable levels.
Read the detailed description
Carrageenan is a naturally occurring plant polysaccharide extracted from edible seaweeds that is widely used in food and beverage products, with a history of use dating back hundreds of years. It is an FDA-approved food additive in the U.S. and has regulatory approval for use as a food ingredient in Europe, Asia, and Latin America.
An earlier clinical trial conducted by the Russian Academy of Sciences demonstrated that consumption of 250 mg/day of carrageenan in capsules, for 28 days, lowered low-density lipoprotein cholesterol (LDL-C) by 34%. In that study, carrageenan consumption also resulted in statistically significant decreases in important biomarkers of chronic inflammation: leukocytes by 16%, fibrinogen by 9%, and C-reactive protein (CRP) by 13%. Another clinical trial conducted by the University of the Philippines showed that carrageenan added to foods led to statistically significant decreases in total cholesterol (total-C) and triglycerides (TG), elevated levels of which are also linked to cardiovascular disease. That study showed that carrageenan consumption led to a 33% reduction in total-C and a 32% reduction in TG.
This is a pilot, open-label, 4 week trial with two screening visits, one baseline visit and two test visits. Subjects will consume 300 mg/day of a proprietary dietary capsule containing carrageenan, with a meal at a consistent time each day, starting at the baseline visit. Fasting blood samples will be collected for lipid profile (total-C, LDL-C, high-density lipoprotein cholesterol [HDL-C], and TG), and high-sensitivity CRP (hs-CRP) measurements at the second screening visit, baseline and the two test visits. Additionally, blood will be drawn for a comprehensive metabolic panel and complete blood count at the second screening and the last test visit only. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, concomitant medication/supplement use, and adverse events will be performed throughout the study. Written study instructions will be provided to the subjects including instructions about fasting, maintenance of adequate hydration, and refraining from vigorous physical activity, alcohol consumption, and tobacco products prior to and during the subsequent visit. At the end of the 4 week test period, subjects will return study product and compliance will be assessed.
- Conditions
- Healthy Volunteers
- Being tested
- 300 mg/day of dietary supplement containing carrageenan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg/day of dietary supplement containing carrageenanDietary supplement
300 mg/day of dietary supplement containing carrageenan.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement with carrageenan | Experimental | 300 mg/day of dietary supplement containing carrageenan Receives: Dietary Supplement: 300 mg/day of dietary supplement containing carrageenan |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C
Percent change in LDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Up to 28 days
Secondary outcomes (6)
Total-C
Percent change in total-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Up to 28 days
HDL-C
Percent change in HDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Upto 28 days
Total-C/HDL-C
Percent change in the ratio of total-C/HDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Up to 28 days
Non-high-density lipoprotein cholesterol (non-HDL-C)
Percent change in non-HDL-C (calculated as total-C minus HDL-C) from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Upto 28 days
Triglycerides (TG)
Percent change in TG from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Up to 28 days
hs-CRP
Change in hs-CRP from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start15 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Midwest Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118583
- Sponsor's protocol ID
- MB-1608
- Status last verified
- May 2018
- First submitted
- 8 Apr 2017
- Last updated
- 15 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Trial to Assess the Effects of a Dietary Supplement on Fasting Lipoprotein Lipids and a Marker of Inflammation in Men and Women With Above-desirable Levels of Low-density Lipoprotein Cholesterol
- ClinicalTrials.gov ID
- NCT03118583
- Acronym / sponsor ID
- MB-1608
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 18 Apr 2017 (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.
The goal of this study is to assess the effects of a dietary supplement on fasting lipoprotein lipids and a marker of inflammation in men and women with levels of low-density lipoprotein cholesterol above desirable levels.
Detailed description
Carrageenan is a naturally occurring plant polysaccharide extracted from edible seaweeds that is widely used in food and beverage products, with a history of use dating back hundreds of years. It is an FDA-approved food additive in the U.S. and has regulatory approval for use as a food ingredient in Europe, Asia, and Latin America.
An earlier clinical trial conducted by the Russian Academy of Sciences demonstrated that consumption of 250 mg/day of carrageenan in capsules, for 28 days, lowered low-density lipoprotein cholesterol (LDL-C) by 34%. In that study, carrageenan consumption also resulted in statistically significant decreases in important biomarkers of chronic inflammation: leukocytes by 16%, fibrinogen by 9%, and C-reactive protein (CRP) by 13%. Another clinical trial conducted by the University of the Philippines showed that carrageenan added to foods led to statistically significant decreases in total cholesterol (total-C) and triglycerides (TG), elevated levels of which are also linked to cardiovascular disease. That study showed that carrageenan consumption led to a 33% reduction in total-C and a 32% reduction in TG.
This is a pilot, open-label, 4 week trial with two screening visits, one baseline visit and two test visits. Subjects will consume 300 mg/day of a proprietary dietary capsule containing carrageenan, with a meal at a consistent time each day, starting at the baseline visit. Fasting blood samples will be collected for lipid profile (total-C, LDL-C, high-density lipoprotein cholesterol [HDL-C], and TG), and high-sensitivity CRP (hs-CRP) measurements at the second screening visit, baseline and the two test visits. Additionally, blood will be drawn for a comprehensive metabolic panel and complete blood count at the second screening and the last test visit only. Assessments of vital signs, body weight, evaluation of inclusion and exclusion criteria, concomitant medication/supplement use, and adverse events will be performed throughout the study. Written study instructions will be provided to the subjects including instructions about fasting, maintenance of adequate hydration, and refraining from vigorous physical activity, alcohol consumption, and tobacco products prior to and during the subsequent visit. At the end of the 4 week test period, subjects will return study product and compliance will be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement with carrageenan | Experimental | Dietary Supplement: 300 mg/day of dietary supplement containing carrageenan300 mg/day of dietary supplement containing carrageenan |
Who may qualify
- Ages
- 25 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index 18.5-34.9 kg/m2
- Judged to be in good health on basis of medical history and screening laboratory tests
- Fasting LDL-C ≥115 mg/dL and <190 mg/dL
Key exclusion criteria (16 listed)
- Abnormal laboratory test results of clinical significance (e.g., TG ≥400 mg/dL, blood glucose ≥126 mg/dL, fasting creatinine ≥1.5 mg/dL, alanine aminotransferase or aspartate aminotransferase ≥1.5X the upper limit of normal)
- Atherosclerotic cardiovascular disease or other evidence of atherosclerotic cardiovascular disease (myocardial infarction or other acute coronary syndrome, coronary or other revascularization procedure, transient ischemic attack, ischemic stroke, atherosclerotic peripheral arterial disease or other documented atherosclerotic diseases)
- Recent major trauma or surgical event
- History or presence of clinically important pulmonary, endocrine, hepatic, renal, hematologic, immunologic, dermatologic, neurologic, psychiatric, or biliary disorders
- History or current gastrointestinal disorder with the potential to disrupt normal digestion and absorption
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 |
|---|---|---|
| 300 mg/day of dietary supplement containing carrageenan300 mg/day of dietary supplement containing carrageenan. | Dietary supplement | Dietary supplement with carrageenan |
Primary outcome
LDL-C
Time frame: Up to 28 days
Percent change in LDL-C from baseline (average of values at days -7 and 0) to end of treatment (average of values at days 21 and 28)
6 secondary outcomes
Total-C
Time frame: Up to 28 days
HDL-C
Time frame: Upto 28 days
Total-C/HDL-C
Time frame: Up to 28 days
Non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: Upto 28 days
Triglycerides (TG)
Time frame: Up to 28 days
hs-CRP
Time frame: Up to 28 days
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 15 May 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Kevin C Maki, PhD study director
Midwest Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 mg/day of dietary supplement containing carrageenan in people with Healthy Volunteers, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
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 3 inclusion and 16 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 15 May 2018. 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 States. 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?
LDL-C (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2018.