Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.

NCT ID: NCT02490683

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-05-31

Brief Summary

This study will test the effect of both Luna Rich X© and Reliv Now© against placebo pills or powder (control) on blood lipids. It will also explore the potential effects of these dietary supplements on inflammation markers and other biological and anthropometric measures. The study intervention will be 30 weeks in length. Twenty four subjects with 2 or more cardiometabolic risk factors will be randomized to participate in the study.

Detailed Description

Primary Objective To test the effects of Luna Rich X©, and Reliv Now© on serum lipids and selected inflammatory and oxidative parameters.

Secondary Objective To explore the potential effects of Luna Rich X© and Reliv Now© on body weight and adiposity.

Hypotheses

1. Eight-week supplementation of formulated lunasin-enriched soy concentrate (Luna Rich X©) in adults at risk for cardiovascular disease will improve their serum lipid profile and reduce inflammatory parameters.

2. Eight-week supplementation of a formulated soy-based powder (Reliv Now) plus Luna Rich X in adults at risk for cardiovascular disease will improve their serum lipid profile and reduce inflammatory parameters.

Study Protocol

Recruitment of Subjects Subjects will be recruited from out-patient clinics in or near Loma Linda University. In collaboration with the medical personnel of the Family and Internal Medicine clinics of the Loma Linda University and Beaver Medical Group, interested clients/patients will be referred to the study. Potential subjects will be informed about the study by the physician, nurse or other clinic personnel and will be given a flyer. Individuals will make their own decision whether or not to participate in the study. The clients/patients who will be interested in participating in the study will contact the investigators via the provided phone numbers. A dedicated telephone line and webpage will provide both additional information to interested individuals and a means to screen out subjects by the study personnel. Potential subjects will first be screened by study personnel, and then directed to a clinical laboratory at Loma Linda University for determination of biochemical parameters on which the eligibility for the study will be determined.

Dietary Interventions

• Luna Rich X©: 500 mg/ day in 4 pills of lunasin-enriched soy protein concentrate
• Reliv Now: 19 grams of powder/day, that subject will mix and consume daily with water or a beverage they commonly drink.
• Control: Placebo pills containing starch (provided by Reliv International, Inc.)

Conditions

Obesity; Cardiovascular Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Luna Rich X

Luna Rich X©: 500 mg/ day in 4 pills of lunasin-enriched soy protein concentrate Reliv Now: 19 grams of powder/day, that subject will mix and consume daily with water or a beverage they commonly drink

Group Type: EXPERIMENTAL

Luna Rich X

Intervention Type: DIETARY_SUPPLEMENT

Reliv Now

19 grams of power/day, that subjects will mix and consume daily with water or a beverage they commonly drink

Group Type: EXPERIMENTAL

Reliv Now

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo pills containing starch (provided by Reliv International, Inc.)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now

Interventions

Luna Rich X

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now

Intervention Type: DIETARY_SUPPLEMENT

Reliv Now

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Men and women 35-75 years of age, at high risk for cardiovascular disease, i.e. with 2 or more risk factors:

• Present tobacco smoker
• Arterial hypertension (BP ≥140/90 mm Hg or treatment)
• LDL-cholesterol ≥130 mg/dl
• HDL-cholesterol ≤ 40 mg/dl
• Triglycerides ≥150 mg/dl
• Fasting blood glucose ≥110 mg/dl
• Overweight or obesity (BMI ≥ 25 kg/m2)
• Family history of premature heart disease

Exclusion Criteria

1. Uncontrolled renal/hepatic/endocrine disease

2. Abnormal blood chemistry profile

3. Familial hypercholesterolemia or other genetic dyslipidaemia

4. Intake of lipid-lowering drugs and dietary products including plant sterols/stanols

5. High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician

6. Hypersensitive or allergic to soy

7. Alcohol or drug addiction/abuse

8. Diabetics

9. Impossibility or lack of interest to follow the dietary intervention

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Joan Sabate,DrPH, MD

DrPH, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan Sabate, DrPH, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda University School of Public Health

Loma Linda, California, United States

Countries

United States

Other Identifiers

5150056

Identifier Type: -

Identifier Source: org_study_id