OverweightNCT01875354
A Prospective Study Investigating the Effects of a Novel Weight Management Program
A study testing Dietary Supplements and TR90 Eating Plan in people with Overweight, run by Pharmanex at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Dietary Supplements and TR90 Eating Plan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18-65 years of age at the time of informed consent
- The ability to read, speak and understand the English language in order to complete the required paper informed consent, assessments and diary
- Access to email and to a digital camera or camera phone
- Willing and able to provide written informed consent
- Willing and able to comply with the study restrictions, procedures and assessments and attend regularly scheduled clinic visits
- Willing and able to accommodate being contacted by the study staff for telephone call visits, follow-up contacts, and study visit reminders
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- BMI is equal to or greater than 25 and less than or equal to 40 kg/m2
- Use of effective method of contraception by females of childbearing potential 30-days before the screening visit and agree to continue to practice that acceptable method of contraception for the duration of her participation in the study
- A resting normotensive blood pressure, as defined as a systolic blood pressure between 150-90 mmHg and a diastolic blood pressure of between 95-50 mmHg, at screening visit 1(A)
- Willing to fast for at least 8 hours prior to the study procedures being performed that require fasting measurements
- Willing and able to follow eating program and able to consume the study supplied Supplements, Placebos and shakes (which include whey and/or egg protein) on a daily basis. Subjects that are lactose intolerant will be considered ineligible
- Only one member per household eligible to participate in the study
Who cannot join
- A subject that has any Axis I Psychiatric disorders according to the DSM-IV criteria that would prevent the subject from being able to comply with study requirements and/or taking anti-psychotic medication
- Diagnosed with insomnia and is chronically using prescribed or OTC insomnia medications
- A self-reported chronic condition that may affect subject safety
- An HbA1c of greater than or equal to 7.0%
- Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less than 50 mL/min/1.73 m2
- Chronically using glucocorticoid steroids
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- Currently pregnant, planning to become pregnant during the course of the study or is breastfeeding
- Use of antihypertensive medication(s) for less than 90 days prior to screening
- Diagnosed with any thyroid disorder or has a clinically significant out of range laboratory value (i.e. TSH, T3 Free, and/or T4 Free) value measured at screening
- Known allergy or intolerance to any of the ingredients contained in the Novel Supplements, placebos or shakes (cow milk proteins)
- Planned surgical procedure during the 365 day course of the study
- Currently participating in another clinical research study or have done so within 30 days prior to the screening visit
- Diagnosis of milk or egg intolerance
- Participating in another weight loss program or using another weight loss product. Subjects may enroll if they are willing to stop the weight loss program they are currently on and/or washout of the product they are using. The appropriate washout will be reviewed with the investigator or medically qualified designee on a case by case basis
- Fasting LDL-C greater than 190 mg/dL or triglycerides greater than 400 mg/dL.
- Unwilling to discontinue consumption of green or black tea or green or black tea extracts beginning at the screening visit and after signing of the informed consent
- Unwilling to discontinue use of over-the-counter and/or prescribed vitamin supplements except for: multivitamins, calcium, fish oil, vitamin C, vitamin D, vitamin E, zinc or iron
- Plans to have plastic or reconstructive surgery or any other procedure that, in the opinion of the investigator, could influence body composition, at any time during the year long study
- Unable to lay supine for at least 30 minutes
- Cognitive impairment that would limit ability to understand or follow diet instructions and/or comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Blinded, Controlled Study Investigating the Effects of a Novel Body Weight Management Program Over 90-days and Weight Maintenance at One Year.
The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program.
- Conditions
- Overweight
- Being tested
- Dietary Supplements and TR90 Eating Plan, Placebo and Low Fat Eating Plan
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplements and TR90 Eating PlanDietary supplement
Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates
Placebo and Low Fat Eating PlanDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Low Fat Eating Plan | Placebo comparator | Placebo Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Placebo Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Placebo Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal)
The placebo group will be instructed to consume every day, a low fat standard of care eating plan delivering approximately 1200-1500 Kcals. Receives: Dietary Supplement: Placebo and Low Fat Eating Plan |
| Dietary Supplements and TR90 Eating Plan | Experimental | Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal)
Experimental group will be instructed to consume every day, dietary supplements and a moderate protein eating plan delivering approximately 1200-1500 Kcals. Receives: Dietary Supplement: Dietary Supplements and TR90 Eating Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of a novel weight management program on body fat mass over 90 days.
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
Measured: Days 0 and 90
Secondary outcomes (8)
Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)
Measured: Throughout 1 year
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
Measured: throughout 1 year
Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)
Measured: Throughout 1 year
Determine skin carotenoid (Biophotonic Scanner) measurement changes.
Biophotonic Scanner utilizes raman spectroscopy to determine skin carotenoid concentrations.
Measured: Throughout 1 year
Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.
Leptin, Insulin, Adiponectin, Pancreatic Polypeptide, gLP1, C-peptide, Glucagon, Resistin and HbA1c
Measured: Days 0 and 90
Evaluate the changes in inflammatory markers from the baseline visit to day 90.
hsCRP, IL-6 and TNF Receptors 60 and 80
Measured: Days 0 and 90
Evaluate the changes in gene expression from the baseline visit to day 90.
Full gene arrays will be made on peripheral blood mononuclear cells. The gene expression changes will be made at baseline and day 90. There will also be a comparison back to proteins (i.e. hormones and inflammatory markers).
Measured: Day 0 and 90
Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365.
Resting metabolic rate (RMR)and substrate utilization (R-values to determine wheather subjects are utilizing more fats or carbohydrates to meet energy demands) will be measured by CPET Quark.
Measured: Days 0, 90, 80, and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Utah State University
- Responsible party
- Sponsor
- Investigators
- Michael Lefevre, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875354
- Sponsor's protocol ID
- 13-PHX-01-NU-02
- Status last verified
- Apr 2017
- First submitted
- 5 Jun 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blinded, Controlled Study Investigating the Effects of a Novel Body Weight Management Program Over 90-days and Weight Maintenance at One Year.
- ClinicalTrials.gov ID
- NCT01875354
- Acronym / sponsor ID
- 13-PHX-01-NU-02
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- PharmanexIndustry (pharma, biotech, devices)
- Collaborators
- Utah State University
- Study start
- May 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Jun 2013 (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.
The purpose of this study is to assess the safety and efficacy of a weight management program composed of dietary supplements and a reduced calorie eating program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo and Low Fat Eating Plan | Placebo comparator | Dietary Supplement: Placebo and Low Fat Eating PlanPlacebo Supplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Placebo Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Placebo Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) The placebo group will be instructed to consume every day, a low fat standard of care eating plan delivering approximately 1200-1500 Kcals. |
| Dietary Supplements and TR90 Eating Plan | Experimental | Dietary Supplement: Dietary Supplements and TR90 Eating PlanSupplement A Powder Mix Days 1 - 15, (1 packet mixed in water or favorite beverage once a day) Supplement B Days 1 - 90, (1 capsule taken three times a day with a meal) Supplement C Days 1 - 90, (2 capsules taken with morning and evening meal) Experimental group will be instructed to consume every day, dietary supplements and a moderate protein eating plan delivering approximately 1200-1500 Kcals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female 18-65 years of age at the time of informed consent
- The ability to read, speak and understand the English language in order to complete the required paper informed consent, assessments and diary
- Access to email and to a digital camera or camera phone
- Willing and able to provide written informed consent
- Willing and able to comply with the study restrictions, procedures and assessments and attend regularly scheduled clinic visits
Key exclusion criteria (20 listed)
- A subject that has any Axis I Psychiatric disorders according to the DSM-IV criteria that would prevent the subject from being able to comply with study requirements and/or taking anti-psychotic medication
- Diagnosed with insomnia and is chronically using prescribed or OTC insomnia medications
- A self-reported chronic condition that may affect subject safety
- An HbA1c of greater than or equal to 7.0%
- Renal insufficiency as defined by a laboratory Glomerular Filtration Rate of less than 50 mL/min/1.73 m2
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 |
|---|---|---|
| Dietary Supplements and TR90 Eating PlanSupplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates | Dietary supplement | Dietary Supplements and TR90 Eating Plan |
| Placebo and Low Fat Eating Plan | Dietary supplement | Placebo and Low Fat Eating Plan |
Primary outcome
Determine the effect of a novel weight management program on body fat mass over 90 days.
Time frame: Days 0 and 90
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
8 secondary outcomes
Determine the safety of novel weight management program (CBC, Comp. metabolic, lipid panel, heart rate, blood pressure and adverse events)
Time frame: Throughout 1 year
Evaluate changes in body measurements (weight and BMI; arm, waist, hip, thigh, claf, and ankle circumferences) and body composition (fat mass, fat free mass, % body fat) by Dual Energy X-ray Absorptiometry (DEXA) scanner.
Time frame: throughout 1 year
Determine subjective measurements of hunger and appetite from standardized questionnaires (IWQOL Hunger/Appetite and overall wellbeing)
Time frame: Throughout 1 year
Determine skin carotenoid (Biophotonic Scanner) measurement changes.
Time frame: Throughout 1 year
Evaluate the changes in metabolism and appetite hormone levels from the baseline visit to day 90.
Time frame: Days 0 and 90
Evaluate the changes in inflammatory markers from the baseline visit to day 90.
Time frame: Days 0 and 90
Evaluate the changes in gene expression from the baseline visit to day 90.
Time frame: Day 0 and 90
Evaluate resting energy expenditure and substrate utilization from baseline to days 90, 180, and 365.
Time frame: Days 0, 90, 80, and 365
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 5 Apr 2017.
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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.
Michael Lefevre, PhD principal investigator
Utah State 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 Dietary Supplements and TR90 Eating Plan in people with Overweight, run by Pharmanex 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 12 inclusion and 20 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 5 Apr 2017. 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?
Determine the effect of a novel weight management program on body fat mass over 90 days. (time frame: Days 0 and 90). 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 5 Apr 2017.