HypercholesterolemiaNCT02835872
A Study to Evaluate the Effects of Dietary Fiber on Blood Lipids in Men and Women
A study testing dietary fiber in people with Hypercholesterolemia, run by Tate & Lyle at 1 site in United States.
Trial summary
There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in order to confirm the product's efficacy. Thus, the objective of this study is to assess the effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women. Read more about this study
- Who is it for?
- Ages 21 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- dietary fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2016
- 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 21 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a generally healthy male or female, 21-79 years of age, inclusive.
- Subject has a BMI of ≥18.50 and ≤35.00 kg/m2 at Visit 1 (Day -14).
- Subject has a fasting LDL-C level ≥130 mg/dL and <190 mg/dL at Visit 1 (Day -14) while receiving no drug therapy. One venous retest allowed for screening subjects within ±3% of the target range (i.e., minimum of 126; maximum of 196 mg/dL). In the event that a redraw is necessary, the average of the two LDL-C values (the redraw value and the Visit 1 value) will be used to determine eligibility.
- Subject has a fasting TG <400 mg/dL at Visit 1 (Day -14). One venous retest allowed for ≥400 mg/dL values.
- Subject is willing to maintain a stable body weight, follow the dietary recommendations, and maintain usual physical activity throughout the study period.
- Subject is willing to maintain usual physical activity level throughout the trial.
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- Subject is a non-user of all tobacco and smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, and e-cigarettes) and has no plans to change status during the study period.
- Subject is a premenopausal female with a history of regular menstrual cycles that range in length from 21 to 35 d, or subject is a post-menopausal female (i.e., has not had regular menstrual cycles for at least one year).
- Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Who cannot join
- Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥126 mg/dL at the screening Visit (Visit 1, Day -14).
- Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, gastrointestinal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's patients), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
- Subject has abnormal laboratory test results of clinical significance at Visit 1 (Day -14), at the discretion of the Clinical Investigator.
- Subject has a known allergy or sensitivity to any of the ingredients in the study products.
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -14). One re-test will be allowed on a separate day prior to Visit 3 (Day 0), for subjects with abnormal blood pressure.
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- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject has had a weight loss or gain >4.5 kg in the 3 months prior to Visit 1 (Day -14).
- Subject has used any medications which can alter the lipid profile, including but not limited to: statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, niacin (drug form), thyroid hormones, or omega-3 ethyl ester drugs within 4 weeks of Visit 1 (Day -14; Appendix 2).
- Subject has used any foods or dietary supplement that might alter lipid metabolism, including but not limited to: omega-3 fatty acid supplements (e.g., flaxseed, fish, or algal oils) or fortified foods, sterol/stanol products; dietary fiber supplements (including Metamucil or viscous fiber-containing supplement); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >400 mg/d (or others at the discretion of the Clinical Investigator) within 2 weeks of Visit 1 (Day -14; Appendix 2).
- Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 4 weeks prior to Visit 1 (Day -14, Appendix 2).
- Subject has an active infection or is using antibiotics within 7 d of the baseline visits (Visits 2 and 3; Days -3).
- Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
- Subject has a history or presence of diagnosed severe premenstrual syndrome and/or premenstrual dysphoric disorder which could interfere with subject compliance.
- Subject has initiated or changed use of hormonal contraceptives within 90 d of Visit 1 (Day -14).
- Subject has been exposed to any non-registered drug product within 30 d prior to visit 1 (Day -14).
- Subject has participated in a clinical trial within 4 weeks of Visit 1 (Day -14).
- Subject has a recent history of (within 12 months of screening; Visit 1, Day -14) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has a lifestyle deemed incompatible with the study according to the Clinical Investigator including high level physical activity (defined as more than 6 hours of vigorous physical activity per week)
- Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Parallel Study to Evaluate the Effects of a Dietary Fiber Ingredient on Blood Lipids in Men and Women
There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in order to confirm the product's efficacy. Thus, the objective of this study is to assess the effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.
Read the detailed description
This study will assess the effect of 3g/d dietary fiber ingredient on lowering serum LDL-C in otherwise healthy men and women. Subjects will be generally healthy men and women (approximately equal number of men and women) 21-79 years of age, inclusive, each with a fasting LDL-C level ≥130 mg/dL and <190 mg/dL.
This randomized, controlled, 28-day parallel study will include one screening Visit (Visit 1, Day -14), two baseline visits (Visits 2 and 3; Days -3 and 0) and three test visits (Visits 4, 5, and 6; Days 14, 25, and 28), and two contact reminders (Days 7 and 21).
Study ingredients will be provided in three servings of study products each day. During the study, subjects will be instructed to consume one serving of study product at each mealtime.
The primary outcome variable will be the percent change in LDL-C concentration from baseline (average of Days -3 and 0) to the end of each intervention condition (average of Days 25 and 28).
- Conditions
- Hypercholesterolemia
- Being tested
- dietary fiber
- Keywords
- fiber, cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiberOther
Fiber containing drink mixes and crackers to be consumed with meals (1g fiber/serving) three times per day for a total of 3 g fiber.
| Study group | Role | What they receive |
|---|---|---|
| Cellulose control | Placebo comparator | 3 g Insoluble Fiber (Cellulose)/d contained within drinks and crackers Receives: Other: dietary fiber |
| Soluble fiber treatment | Active comparator | 3 g soluble dietary fiber test ingredient contained within drinks and crackers Receives: Other: dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL Cholesterol
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Change in Total cholesterol
Measured: Baseline and 4 weeks
Change in HDL- Cholesterol
Measured: Baseline and 4 weeks
Change in Non-HDL- Cholesterol
Measured: Baseline and 4 weeks
Change in Triglycerides
Measured: Baseline and 4 weeks
Total / HDL Cholesterol Ratio
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tate & Lyle
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835872
- Sponsor's protocol ID
- BIO1604
- Status last verified
- Sep 2016
- First submitted
- 7 Jul 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Individual data sharing
- Undecided: No plan to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Study to Evaluate the Effects of a Dietary Fiber Ingredient on Blood Lipids in Men and Women
- ClinicalTrials.gov ID
- NCT02835872
- Acronym / sponsor ID
- BIO1604
- Conditions
- Hypercholesterolemia
- Keywords
- fiber, cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tate & LyleIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in order to confirm the product's efficacy. Thus, the objective of this study is to assess the effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.
Detailed description
This study will assess the effect of 3g/d dietary fiber ingredient on lowering serum LDL-C in otherwise healthy men and women. Subjects will be generally healthy men and women (approximately equal number of men and women) 21-79 years of age, inclusive, each with a fasting LDL-C level ≥130 mg/dL and <190 mg/dL.
This randomized, controlled, 28-day parallel study will include one screening Visit (Visit 1, Day -14), two baseline visits (Visits 2 and 3; Days -3 and 0) and three test visits (Visits 4, 5, and 6; Days 14, 25, and 28), and two contact reminders (Days 7 and 21).
Study ingredients will be provided in three servings of study products each day. During the study, subjects will be instructed to consume one serving of study product at each mealtime.
The primary outcome variable will be the percent change in LDL-C concentration from baseline (average of Days -3 and 0) to the end of each intervention condition (average of Days 25 and 28).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellulose control | Placebo comparator | Other: dietary fiber3 g Insoluble Fiber (Cellulose)/d contained within drinks and crackers |
| Soluble fiber treatment | Active comparator | Other: dietary fiber3 g soluble dietary fiber test ingredient contained within drinks and crackers |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is a generally healthy male or female, 21-79 years of age, inclusive.
- Subject has a BMI of ≥18.50 and ≤35.00 kg/m2 at Visit 1 (Day -14).
- Subject has a fasting LDL-C level ≥130 mg/dL and <190 mg/dL at Visit 1 (Day -14) while receiving no drug therapy. One venous retest allowed for screening subjects within ±3% of the target range (i.e., minimum of 126; maximum of 196 mg/dL). In the event that a redraw is necessary, the average of the two LDL-C values (the redraw value and the Visit 1 value) will be used to determine eligibility.
- Subject has a fasting TG <400 mg/dL at Visit 1 (Day -14). One venous retest allowed for ≥400 mg/dL values.
- Subject is willing to maintain a stable body weight, follow the dietary recommendations, and maintain usual physical activity throughout the study period.
Key exclusion criteria (20 listed)
- Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥126 mg/dL at the screening Visit (Visit 1, Day -14).
- Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, gastrointestinal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's patients), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
- Subject has abnormal laboratory test results of clinical significance at Visit 1 (Day -14), at the discretion of the Clinical Investigator.
- Subject has a known allergy or sensitivity to any of the ingredients in the study products.
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
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 |
|---|---|---|
| dietary fiberFiber containing drink mixes and crackers to be consumed with meals (1g fiber/serving) three times per day for a total of 3 g fiber. | Other | Cellulose control, Soluble fiber treatment |
Primary outcome
Change in LDL Cholesterol
Time frame: Baseline and 4 weeks
5 secondary outcomes
Change in Total cholesterol
Time frame: Baseline and 4 weeks
Change in HDL- Cholesterol
Time frame: Baseline and 4 weeks
Change in Non-HDL- Cholesterol
Time frame: Baseline and 4 weeks
Change in Triglycerides
Time frame: Baseline and 4 weeks
Total / HDL Cholesterol Ratio
Time frame: Baseline and 4 weeks
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 28 Sep 2016.
- Individual participant dataSharing planned: Undecided. No plan to share data at this time.
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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?
A study testing dietary fiber in people with Hypercholesterolemia, run by Tate & Lyle 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 10 inclusion and 20 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 28 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Change in LDL Cholesterol (time frame: Baseline and 4 weeks). 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 28 Sep 2016.