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

NCT04277741 | Withdrawn

• 1 other identifier: Pro9978
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in plasma lipids

  Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state

  Week 0, 4, and 8

Secondary Outcomes (3)

• Change in body composition

  Week 0, 4, and 8

• Change in BMI

  Week 0, 4, and 8

• Change in homeostatic model assessment for insulin resistance (HOMA-IR)

  Week 0,4, and 8

Study Arms (2)

Resistant starch bar

EXPERIMENTAL

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

Dietary Supplement: RS4 bar

Native wheat bar

ACTIVE COMPARATOR

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

Dietary Supplement: Control bar

Interventions

RS4 bar DIETARY_SUPPLEMENT

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

Resistant starch bar

Control bar DIETARY_SUPPLEMENT

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

Native wheat bar

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 23 kg/m2
• elevated to borderline-high LDL-cholesterol (116-159 mg/dL)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kansas State University: lead
• MGP Ingredients, Inc.: collaborator

Study Sites (1)

Physical Activity and Nutrition Clinical Research Consortium

Manhattan, Kansas, 66502, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Overweight; Obesity

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara Rosenkranz, PhD

  Kansas State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be blind to the condition that they are in.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: February 18, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)