ObesityNCT02490683
Effects of Soy Based Dietary Supplements on Cardiometabolic Risk Factors.
A study testing Luna Rich X and Reliv Now in people with Obesity and Cardiovascular Risk Factors, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Obesity, Cardiovascular Risk Factors
- What is being tested?
- Luna Rich X and Reliv Now
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Fasting blood glucose ≥110 mg/dl
- Overweight or obesity (BMI ≥ 25 kg/m2)
- Family history of premature heart disease
Who cannot join
- 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
Show all 9Show fewer
- Alcohol or drug addiction/abuse
- Diabetics
- Impossibility or lack of interest to follow the dietary intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
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.
Read the 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
- 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.
- 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
- Being tested
- Luna Rich X, Placebo, Reliv Now
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luna Rich XDietary supplement
PlaceboDietary supplement
Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now
Reliv NowDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Reliv Now |
| Placebo | Placebo comparator | Placebo pills containing starch (provided by Reliv International, Inc.) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline- 30 weeks
Secondary outcomes (2)
Hormones
: adiponectin, leptin, insulin, C-peptide (C-peptide of insulin); and fasting glucose and hemoglobin A1c. will be measured via lab tests
Measured: baseline- 30 weeks
Compliance
, blood samples will be taken for testing levels of lunasin and/or its metabolites as biological marker(s) of the treatment compliance.
Measured: baseline -30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
- Investigators
- Joan Sabate, DrPH, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490683
- Sponsor's protocol ID
- 5150056
- Status last verified
- May 2016
- First submitted
- 2 Jul 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soy-based Dietary Supplements on Cardiometabolic Risk Factors in Individuals at High Risk for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02490683
- Acronym / sponsor ID
- 5150056
- Conditions
- Obesity, Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Luna Rich X | Experimental | Dietary Supplement: Luna Rich XLuna 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 |
| Reliv Now | Experimental | Dietary Supplement: Reliv Now19 grams of power/day, that subjects will mix and consume daily with water or a beverage they commonly drink |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo pills containing starch (provided by Reliv International, Inc.) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luna Rich X | Dietary supplement | Luna Rich X |
| PlaceboStarch pill/or powder manufactured to mimic Luna Rich X and Reliv Now | Dietary supplement | Placebo |
| Reliv Now | Dietary supplement | Reliv Now |
Primary outcome
Serum Lipid profile
Time frame: baseline- 30 weeks
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.
Inflammatory and oxidative parameters
Time frame: baseline- 30 weeks
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
2 secondary outcomes
Hormones
Time frame: baseline- 30 weeks
Compliance
Time frame: baseline -30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Sabate, DrPH, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luna Rich X and Reliv Now in people with Obesity and Cardiovascular Risk Factors, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Lipid profile (time frame: baseline- 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.