Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04277741 |
| Other study ID # |
Pro9978 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2020 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Kansas State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
