NCT02490683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

July 2, 2015

Last Update Submit

May 10, 2016

Conditions

ObesityCardiovascular Risk Factors

Outcome Measures

Primary Outcomes (2)

  • Serum Lipid profile

    Serum Low density cholesterol, high density cholesterol, apo Lipoprotein A and B, apo E allele genetic typing and triglycerides will be measured from the by performing lab tests.

    baseline- 30 weeks

  • Inflammatory and oxidative parameters

    hs-CRP (highly sensitive C-reactive protein), TNF-alpha (tissue necrosis factor alpha), IL-6 (Interleukin 6), ox-LDL (oxidized low density lipoprotein), TBARS (thiobarbituric acid reactive substances) lipid peroxides, 8-OHdG (8-hydroxy-2-deoxyguanosine) will be measured via lab tests

    baseline- 30 weeks

Secondary Outcomes (2)

  • Hormones

    baseline- 30 weeks

  • Compliance

    baseline -30 weeks

Study Arms (3)

Luna Rich X

EXPERIMENTAL

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

Dietary Supplement: Luna Rich X

Reliv Now

EXPERIMENTAL

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

Dietary Supplement: Reliv Now

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Luna Rich XDIETARY_SUPPLEMENT
Luna Rich X
PlaceboDIETARY_SUPPLEMENT

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

Placebo
Reliv NowDIETARY_SUPPLEMENT
Reliv Now

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • Uncontrolled renal/hepatic/endocrine disease
  • Abnormal blood chemistry profile
  • Familial hypercholesterolemia or other genetic dyslipidaemia
  • Intake of lipid-lowering drugs and dietary products including plant sterols/stanols
  • High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician
  • Hypersensitive or allergic to soy
  • Alcohol or drug addiction/abuse
  • Diabetics
  • Impossibility or lack of interest to follow the dietary intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joan Sabate, DrPH, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DrPH, MD

Study Record Dates

First Submitted

July 2, 2015

First Posted

July 7, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)