Long-term Consumption of Resistant Starch Type-4 (RS4)
Long-term Consumption of Resistant Starch Type-4 (RS4)
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.
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.
Inclusion Criteria:

 -  BMI ≥ 23 kg/m2

 -  elevated to borderline-high LDL-cholesterol (116-159 mg/dL)

 Exclusion Criteria:

 -  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

 -  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.