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Long-term Consumption of Resistant Starch Type-4 (RS4)

NCT04277741 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Cholesterol, Elevated
  • Overweight or Obesity

Interventions

DIETARY_SUPPLEMENT

RS4 bar

The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber.

DIETARY_SUPPLEMENT

Control bar

The control group will consume one native wheat starch bar per day.

Sponsors & Collaborators

  • MGP Ingredients, Inc.

    collaborator INDUSTRY

  • Kansas State University

    lead OTHER

Principal Investigators

  • Sara Rosenkranz, PhD · Kansas State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04277741 on ClinicalTrials.gov