Cholesterol, ElevatedNCT04277741
Long-term Consumption of Resistant Starch Type-4 (RS4)
A study testing RS4 bar in people with Cholesterol, Elevated and Overweight or Obesity, run by Kansas State University at 1 site in United States.
Trial summary
The primary objective of the current proposal is to determine the effectiveness of long-term consumption of Fibersym® RW for improving blood lipids (including cholesterol) and body composition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol, Elevated, Overweight or Obesity
- What is being tested?
- RS4 bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 30 Jun 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 23 kg/m2
- elevated to borderline-high LDL-cholesterol (116-159 mg/dL)
Who cannot join
- known allergy to wheat or gluten
- currently taking medication for chronic disease including anti-inflammatory, anti-hypertensive, lipid lowering, glucose controlling, or steroidal medications
- taking any supplements that may affect metabolism
- having anemia or a history of anemia
- current smoker or a user in the past three months
- currently pregnant or lactating/planning to become pregnant during the intervention
Show all 9Show fewer
- having elevated blood pressure (≥130mmHg/≥80mmHg)
- presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions that may affect metabolic processes
- total cholesterol ≥ 240mg/dL.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Nutrition Clinical Research Consortium
Manhattan, Kansas, 66502
About this study
Official title: Long-term Consumption of Resistant Starch Type-4 (RS4): Implications for Obesity and Chronic Disease
The primary objective of the current proposal is to determine the effectiveness of long-term consumption of Fibersym® RW for improving blood lipids (including cholesterol) and body composition. The overall goal of this clinical research is to determine the potential effects that RS4 consumption may have on the prevention of obesity and obesity-related diseases. Fiber in the form of RS4 will be used for the proposed study, given that fiber has been shown to have many beneficial effects on modifiable risk factors associated with obesity-related diseases. Using a long-term randomized-controlled intervention design, blood lipids (total cholesterol, LDL-c, HDL-c, triglycerides) and body composition will be assessed. The investigators anticipate reductions in cholesterol and body fat percentage following 8-weeks of Fibersym® RW consumption.
Read the detailed description
This study will investigate the metabolic effects of daily RS4 consumption in overweight and obese adults. The investigators will recruit approximately 50 (BMI: 23-34.9kg/m2) adults ages 18-65yrs, who have elevated to borderline-high LDL-cholesterol (116-159mg/dL) to an 8-week randomized controlled intervention. Participants will be recruited in three waves of 16 participants each. Following a 7-10-day run-in where fiber intake is monitored, participants will be randomized to either the control or the RS4 group. The RS4 group will consume a high fiber bar, daily, for 8-weeks that will contain approximately 60-70% of the daily reccomended allowance of fiber. The primary outcome for this study will be fasting plasma LDL-Cholesterol (LDL-c). Secondary outcomes include body composition following daily RS4 consumption for 8-weeks. All health assessments will be conducted before the intervention begins, at the 4-week mid-point, and immediately following the 8-week intervention. Participants will fast for 10 -12 hrs. before reporting to the PAN-CRC for each testing session. The meal consumed prior to each testing session will be standardized so that it does not vary within the individual between testing sessions.
Treatments. The two treatment conditions are RS4 and control. Participants will be asked to consume one nutrition bar as part of their breakfast each day with no other changes to their diet. The control group will consume one native wheat starch bar per day. The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber. This amount would likely put individuals in the recommended dietary fiber intake range according to the dietary recommended intake ( Institutes of Medicine: 14g fiber/1000 kcal). All nutrition bars will contain the same ingredients and be matched for calories; however, fiber will vary between the bars.
Health assessments. The KSU Nutrition team will conduct all health assessments at each time point. Height (cm), weight (kg), and waist circumference (cm) will be measured to determine basic anthropometrics, and a dual-energy X-ray absorptiometry scan (DXA) will be used to determine body composition (body fat percentage and non-fat mass). Blood pressure (systolic and diastolic (mmHg) will be measured using a standard automated monitor. Fasting total cholesterol (TC), triglycerides (TRG), glucose, LDL-c, and HDL-c will be measured via an LDX Cholestech using a single venous blood draw for assessment. Plasma glucose and insulin will be determined via the same venous sample. Satiety will be measured during each testing session to determine how Fibersym® RW impacts feelings of fullness and hunger.
Compliance Checks. To ensure compliance with consumption of the nutrition bars provided, participants will be asked to return to the PAN-CRC to return any leftover bars at the end of each intervention week (if any remain), and to pick up a new supply of their assigned bar. Participants will also be given a checklist that indicates their daily consumption of the given bars. The checklist will include options such as: I consumed the 100% of the bar, forgot to consume, consumed part of the bar (with options to check a percent of the bar consumed). To ensure that habitual dietary intake is maintained, participants will be instructed to complete a 3-day dietary record (two weekdays and 1 weekend day) prior to each testing session, allowing the investigators to determine any dietary changes that may occur during the 8-week intervention.
- Conditions
- Cholesterol, Elevated, Overweight or Obesity
- Being tested
- RS4 bar, Control bar
- Medical subject headings
- Hypercholesterolemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS4 barDietary supplement
The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber.
Control barDietary supplement
The control group will consume one native wheat starch bar per day.
| Study group | Role | What they receive |
|---|---|---|
| Resistant starch bar | Experimental | The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW. Receives: Dietary Supplement: RS4 bar |
| Native wheat bar | Active comparator | The control group will consume one native wheat starch bar per day. Receives: Dietary Supplement: Control bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma lipids
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state
Measured: Week 0, 4, and 8
Secondary outcomes (3)
Change in body composition
Percent body fat as measured by DXA scan
Measured: Week 0, 4, and 8
Change in BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: Week 0, 4, and 8
Change in homeostatic model assessment for insulin resistance (HOMA-IR)
Calculated from fasting glucose and insulin levels
Measured: Week 0,4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start18 Feb 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023
Why it stopped: PI departure from university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol, ElevatedStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Responsible party
- Principal investigator, Sara K Rosenkranz, Kansas State University
- Investigators
- Sara Rosenkranz, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277741
- Sponsor's protocol ID
- Pro9978
- Status last verified
- Oct 2023
- First submitted
- 18 Feb 2020
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Consumption of Resistant Starch Type-4 (RS4): Implications for Obesity and Chronic Disease
- ClinicalTrials.gov ID
- NCT04277741
- Acronym / sponsor ID
- Pro9978
- Conditions
- Cholesterol, Elevated, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI departure from university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Collaborators
- MGP Ingredients, Inc.
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Feb 2020 (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 primary objective of the current proposal is to determine the effectiveness of long-term consumption of Fibersym® RW for improving blood lipids (including cholesterol) and body composition. The overall goal of this clinical research is to determine the potential effects that RS4 consumption may have on the prevention of obesity and obesity-related diseases. Fiber in the form of RS4 will be used for the proposed study, given that fiber has been shown to have many beneficial effects on modifiable risk factors associated with obesity-related diseases. Using a long-term randomized-controlled intervention design, blood lipids (total cholesterol, LDL-c, HDL-c, triglycerides) and body composition will be assessed. The investigators anticipate reductions in cholesterol and body fat percentage following 8-weeks of Fibersym® RW consumption.
Detailed description
This study will investigate the metabolic effects of daily RS4 consumption in overweight and obese adults. The investigators will recruit approximately 50 (BMI: 23-34.9kg/m2) adults ages 18-65yrs, who have elevated to borderline-high LDL-cholesterol (116-159mg/dL) to an 8-week randomized controlled intervention. Participants will be recruited in three waves of 16 participants each. Following a 7-10-day run-in where fiber intake is monitored, participants will be randomized to either the control or the RS4 group. The RS4 group will consume a high fiber bar, daily, for 8-weeks that will contain approximately 60-70% of the daily reccomended allowance of fiber. The primary outcome for this study will be fasting plasma LDL-Cholesterol (LDL-c). Secondary outcomes include body composition following daily RS4 consumption for 8-weeks. All health assessments will be conducted before the intervention begins, at the 4-week mid-point, and immediately following the 8-week intervention. Participants will fast for 10 -12 hrs. before reporting to the PAN-CRC for each testing session. The meal consumed prior to each testing session will be standardized so that it does not vary within the individual between testing sessions.
Treatments. The two treatment conditions are RS4 and control. Participants will be asked to consume one nutrition bar as part of their breakfast each day with no other changes to their diet. The control group will consume one native wheat starch bar per day. The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber. This amount would likely put individuals in the recommended dietary fiber intake range according to the dietary recommended intake ( Institutes of Medicine: 14g fiber/1000 kcal). All nutrition bars will contain the same ingredients and be matched for calories; however, fiber will vary between the bars.
Health assessments. The KSU Nutrition team will conduct all health assessments at each time point. Height (cm), weight (kg), and waist circumference (cm) will be measured to determine basic anthropometrics, and a dual-energy X-ray absorptiometry scan (DXA) will be used to determine body composition (body fat percentage and non-fat mass). Blood pressure (systolic and diastolic (mmHg) will be measured using a standard automated monitor. Fasting total cholesterol (TC), triglycerides (TRG), glucose, LDL-c, and HDL-c will be measured via an LDX Cholestech using a single venous blood draw for assessment. Plasma glucose and insulin will be determined via the same venous sample. Satiety will be measured during each testing session to determine how Fibersym® RW impacts feelings of fullness and hunger.
Compliance Checks. To ensure compliance with consumption of the nutrition bars provided, participants will be asked to return to the PAN-CRC to return any leftover bars at the end of each intervention week (if any remain), and to pick up a new supply of their assigned bar. Participants will also be given a checklist that indicates their daily consumption of the given bars. The checklist will include options such as: I consumed the 100% of the bar, forgot to consume, consumed part of the bar (with options to check a percent of the bar consumed). To ensure that habitual dietary intake is maintained, participants will be instructed to complete a 3-day dietary record (two weekdays and 1 weekend day) prior to each testing session, allowing the investigators to determine any dietary changes that may occur during the 8-week intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistant starch bar | Experimental | Dietary Supplement: RS4 barThe RS4 group will consume one nutrition bar per day formulated using Fibersym® RW. |
| Native wheat bar | Active comparator | Dietary Supplement: Control barThe control group will consume one native wheat starch bar per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 23 kg/m2
- elevated to borderline-high LDL-cholesterol (116-159 mg/dL)
Key exclusion criteria (9 listed)
- known allergy to wheat or gluten
- currently taking medication for chronic disease including anti-inflammatory, anti-hypertensive, lipid lowering, glucose controlling, or steroidal medications
- taking any supplements that may affect metabolism
- having anemia or a history of anemia
- current smoker or a user in the past three months
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 |
|---|---|---|
| RS4 barThe RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber. | Dietary supplement | Resistant starch bar |
| Control barThe control group will consume one native wheat starch bar per day. | Dietary supplement | Native wheat bar |
Primary outcome
Change in plasma lipids
Time frame: Week 0, 4, and 8
Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state
3 secondary outcomes
Change in body composition
Time frame: Week 0, 4, and 8
Change in BMI
Time frame: Week 0, 4, and 8
Change in homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: Week 0,4, and 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Sara Rosenkranz, PhD principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS4 bar in people with Cholesterol, Elevated and Overweight or Obesity, run by Kansas State University 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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 4 Oct 2023. 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 was withdrawn before enrolling participants, so there are no results.
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 plasma lipids (time frame: Week 0, 4, and 8). 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 4 Oct 2023.