NCT02835872

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tate & Lyle · Industry
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
OTHER	dietary fiber	Fiber containing drink mixes and crackers to be consumed with meals (1g fiber/serving) three times per day for a total of 3 g fiber.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-07-18
• Last updated: 2016-09-28

Locations

1 site across 1 country: United States