A Study to Evaluate the Effects of Dietary Fiber on Blood Lipids in Men and Women

Hypercholesterolemia Clinical Trial

Official title: A Randomized, Double-Blind, Parallel Study to Evaluate the Effects of a Dietary Fiber Ingredient on Blood Lipids in Men and Women

Status Completed

Clinical Trial Summary

There is a need to assess the LDL-C-lowering abilities of a dietary fiber ingredient, in order to confirm the product's efficacy. Thus, the objective of this study is to assess the effect of 3g dietary fiber on lowering serum LDL-C in otherwise healthy men and women.

Clinical Trial Description

This study will assess the effect of 3g/d dietary fiber ingredient on lowering serum LDL-C in otherwise healthy men and women. Subjects will be generally healthy men and women (approximately equal number of men and women) 21-79 years of age, inclusive, each with a fasting LDL-C level ≥130 mg/dL and <190 mg/dL.

This randomized, controlled, 28-day parallel study will include one screening Visit (Visit 1, Day -14), two baseline visits (Visits 2 and 3; Days -3 and 0) and three test visits (Visits 4, 5, and 6; Days 14, 25, and 28), and two contact reminders (Days 7 and 21).

Study ingredients will be provided in three servings of study products each day. During the study, subjects will be instructed to consume one serving of study product at each mealtime.

The primary outcome variable will be the percent change in LDL-C concentration from baseline (average of Days -3 and 0) to the end of each intervention condition (average of Days 25 and 28). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT02835872
• Study type: Interventional
• Source: Tate & Lyle
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Completion date: September 2016