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

NCT02835872 | Completed

• 1 other identifier: BIO1604
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypercholesterolemia

Keywords

fiber; cholesterol

Outcome Measures

Primary Outcomes (1)

• Change in LDL Cholesterol

  Baseline and 4 weeks

Secondary Outcomes (5)

• Change in Total cholesterol

  Baseline and 4 weeks

• Change in HDL- Cholesterol

  Baseline and 4 weeks

• Change in Non-HDL- Cholesterol

  Baseline and 4 weeks

• Change in Triglycerides

  Baseline and 4 weeks

• Total / HDL Cholesterol Ratio

  Baseline and 4 weeks

Study Arms (2)

Cellulose control

PLACEBO COMPARATOR

3 g Insoluble Fiber (Cellulose)/d contained within drinks and crackers

Other: dietary fiber

Soluble fiber treatment

ACTIVE COMPARATOR

3 g soluble dietary fiber test ingredient contained within drinks and crackers

Other: dietary fiber

Interventions

dietary fiber OTHER

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.

Cellulose control; Soluble fiber treatment

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a generally healthy male or female, 21-79 years of age, inclusive.
• Subject has a BMI of ≥18.50 and ≤35.00 kg/m2 at Visit 1 (Day -14).
• Subject has a fasting LDL-C level ≥130 mg/dL and \<190 mg/dL at Visit 1 (Day -14) while receiving no drug therapy. One venous retest allowed for screening subjects within ±3% of the target range (i.e., minimum of 126; maximum of 196 mg/dL). In the event that a redraw is necessary, the average of the two LDL-C values (the redraw value and the Visit 1 value) will be used to determine eligibility.
• Subject has a fasting TG \<400 mg/dL at Visit 1 (Day -14). One venous retest allowed for ≥400 mg/dL values.
• Subject is willing to maintain a stable body weight, follow the dietary recommendations, and maintain usual physical activity throughout the study period.
• Subject is willing to maintain usual physical activity level throughout the trial.
• Subject is a non-user of all tobacco and smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, and e-cigarettes) and has no plans to change status during the study period.
• Subject is a premenopausal female with a history of regular menstrual cycles that range in length from 21 to 35 d, or subject is a post-menopausal female (i.e., has not had regular menstrual cycles for at least one year).
• Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
• Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.

You may not qualify if:

• Subject has diagnosed diabetes mellitus (Type 1 or Type 2) or fasting glucose ≥126 mg/dL at the screening Visit (Visit 1, Day -14).
• Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, gastrointestinal, endocrine, hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's patients), psychiatric (including depression and/or anxiety disorders) or biliary disorders.
• Subject has abnormal laboratory test results of clinical significance at Visit 1 (Day -14), at the discretion of the Clinical Investigator.
• Subject has a known allergy or sensitivity to any of the ingredients in the study products.
• Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian), in the opinion of the Clinical Investigator.
• Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -14). One re-test will be allowed on a separate day prior to Visit 3 (Day 0), for subjects with abnormal blood pressure.
• Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Subject has had a weight loss or gain \>4.5 kg in the 3 months prior to Visit 1 (Day -14).
• Subject has used any medications which can alter the lipid profile, including but not limited to: statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, niacin (drug form), thyroid hormones, or omega-3 ethyl ester drugs within 4 weeks of Visit 1 (Day -14; Appendix 2).
• Subject has used any foods or dietary supplement that might alter lipid metabolism, including but not limited to: omega-3 fatty acid supplements (e.g., flaxseed, fish, or algal oils) or fortified foods, sterol/stanol products; dietary fiber supplements (including Metamucil or viscous fiber-containing supplement); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses \>400 mg/d (or others at the discretion of the Clinical Investigator) within 2 weeks of Visit 1 (Day -14; Appendix 2).
• Subject has used weight-loss drugs (including over-the-counter medications and/or supplements) or programs within 4 weeks prior to Visit 1 (Day -14, Appendix 2).
• Subject has an active infection or is using antibiotics within 7 d of the baseline visits (Visits 2 and 3; Days -3).
• Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
• Subject has a history or presence of diagnosed severe premenstrual syndrome and/or premenstrual dysphoric disorder which could interfere with subject compliance.
• Subject has initiated or changed use of hormonal contraceptives within 90 d of Visit 1 (Day -14).

Sponsors & Collaborators

• Tate & Lyle: lead
• BioFortis: collaborator

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 18, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)