Clinical trial NCT02490683: Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.
Official title: The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Risk Factors
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.)

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

Primary outcomes:
measure: Serum Lipid profile
timeFrame: baseline- 30 weeks
measure: Inflammatory and oxidative parameters
timeFrame: baseline- 30 weeks
Secondary outcomes:
measure: Hormones
timeFrame: baseline- 30 weeks
measure: Compliance
timeFrame: baseline -30 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH, MD
role: PRINCIPAL_INVESTIGATOR
References: