ObesityNCT03098056
Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2
A study testing PROG2 in people with Obesity, run by Nature's Sunshine Products, Inc..
Trial summary
The study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. Experience will be compared to a historical controls. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- PROG2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required:
- to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2),
- to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men),
- and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have:
- elevated LDL cholesterol ≥ 130 mg/dl
- and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated LDL and TG):
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- HDL < 50 mg/dl for women and < 40 mg/dl for men,
- blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7%,
- or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥ 2.0.
Who cannot join
- Pregnancy
- Lactation
- Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements
- Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia
- Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
- Allergy or intolerance to study products
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- Serious, unstable medical conditions including known infection with HIV, tuberculosis or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse;
- Abnormal laboratory findings
- Participating in or planning to begin a weight loss diet during the study period
- Difficulty in swallowing pills
- Lifestyle or schedule incompatible with the study protocol.
About this study
Official title: Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function - Second Phase
The study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. Experience will be compared to a historical controls.
Read the detailed description
To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education and a meal replacement formula and targeted nutraceuticals (PROG 2) in generally healthy, overweight subjects, fifty subjects with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into different arms, 13-week intervention trial. To evaluate safety and tolerability, questionnaires were collected weekly. Additionally, baseline, week 9 and 13 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Vitals signs, weight and body composition were monitored weekly.
- Conditions
- Obesity
- Being tested
- PROG2
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROG2Other
Nutritional Supplements to be administered:
- Protein Shakes: one shake po twice daily
- Phytosterol supplement: one capsule po twice daily
- Cinnamon: one tablet twice daily
- Fiber supplement; one shake twice daily
- Antioxidant supplement: 2 capsules daily with dinner
- Fish Oil supplement: 1 capsule twice daily with food
- Probiotic supplement: 1 capsule twice daily with food
| Study group | Role | What they receive |
|---|---|---|
| PROG2 | Experimental | All subjects will be participating in a lifestyle change program - specifically a high protein, limited carbohydrate food plan (High Phyto-PRO food plan), physical activity and a cognitive behavioral program consisting of 11 group visit. Participants will be recieving nutritional Supplements. Receives: Other: PROG2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Data collection including questionnaires at individual and group visits and physician interviews at individual visits (baseline, week 9 and week 13) will be used to assess participants for treatment-related adverse events.
Measured: 13 weeks
Secondary outcomes (16)
Number of participants with treatment-related changes in basic safety labs
Phlebotomy will be conducted at individual visits (baseline, week 9 and week 13). Comprehensive Metabolic Panels and Complete Blood Counts will be assessed for treatment-related change from baseline.
Measured: 13 weeks
Number of participants with treatment-related changes in vital signs
Blood pressure and peripheral pulse will be monitored at individual visits (baseline, week 9 and week 13). Comprehensive Metabolic Panels and Complete Blood Counts will be assessed for treatment-related change from baseline.
Measured: 13 weeks
Change in weight in pounds compared to baseline
Weight in pounds will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in body fat in percentage compared to baseline
Body fat in percentage will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in BMI in kg/m2 compared to baseline
BMI in kg/m2 will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in waist circumference in inches compared to baseline
Waist circumference in inches will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in Total Cholesterol in mg/dl compared to baseline
Total Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in LDL-Cholesterol in mg/dl compared to baseline
LDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in oxidized LDL-Cholesterol in mg/dl compared to baseline
Oxidized LDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in HDL-Cholesterol in mg/dl compared to baseline
HDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in Triglycerides in mg/dl compared to baseline
Triglycerides in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in fasting glucose in mg/dl compared to baseline
Fasting glucose in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in fasting Insulin in mIU/l compared to baseline
Fasting Insulin in mIU/l will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in Hemoglobin A1c in percentage in mIU/l compared to baseline
Hemoglobin A1c in percentage will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in Metabolic Syndrome Score compared to baseline
A Metabolic Syndrome score (0-5) will be calculated for participants at individual visits (baseline, week 9 and week 13). The five features of Metabolic Syndrome (visceral adiposity based on waist circumference, hyperglycemia, hypertension (or use of antihypertensives), hypertriglyceridemia and low HDL-Cholesterol will each be assigned a point value of 1. Subjects will receive 1 point for each feature they demonstrate on collected data. Score will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Change in Framingham Risk Assessment Score compared to baseline
The Framingham Risk Assessment Score will be calculated for participants at individual visits (baseline, week 9 and week 13). Score will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Aug 2016
- Primary completion18 Nov 2016
- Study completion31 Dec 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature's Sunshine Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph J Lamb, MD, Principal investigator, Hughes Center for Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098056
- Sponsor's protocol ID
- NSP-CT-010
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function - Second Phase
- ClinicalTrials.gov ID
- NCT03098056
- Acronym / sponsor ID
- NSP-CT-010
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nature's Sunshine Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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 study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. Experience will be compared to a historical controls.
Detailed description
To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education and a meal replacement formula and targeted nutraceuticals (PROG 2) in generally healthy, overweight subjects, fifty subjects with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into different arms, 13-week intervention trial. To evaluate safety and tolerability, questionnaires were collected weekly. Additionally, baseline, week 9 and 13 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Vitals signs, weight and body composition were monitored weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROG2 | Experimental | Other: PROG2All subjects will be participating in a lifestyle change program - specifically a high protein, limited carbohydrate food plan (High Phyto-PRO food plan), physical activity and a cognitive behavioral program consisting of 11 group visit. Participants will be recieving nutritional Supplements. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2),
- to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men),
- and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have:
- elevated LDL cholesterol ≥ 130 mg/dl
- and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated LDL and TG):
Key exclusion criteria (11 listed)
- Pregnancy
- Lactation
- Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements
- Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia
- Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
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 |
|---|---|---|
| PROG2Nutritional Supplements to be administered: * Protein Shakes: one shake po twice daily * Phytosterol supplement: one capsule po twice daily * Cinnamon: one tablet twice daily * Fiber supplement; one shake twice daily * Antioxidant supplement: 2 capsules daily with dinner * Fish Oil supplement: 1 capsule twice daily with food * Probiotic supplement: 1 capsule twice daily with food | Other | PROG2 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: 13 weeks
Data collection including questionnaires at individual and group visits and physician interviews at individual visits (baseline, week 9 and week 13) will be used to assess participants for treatment-related adverse events.
16 secondary outcomes
Number of participants with treatment-related changes in basic safety labs
Time frame: 13 weeks
Number of participants with treatment-related changes in vital signs
Time frame: 13 weeks
Change in weight in pounds compared to baseline
Time frame: 13 weeks
Change in body fat in percentage compared to baseline
Time frame: 13 weeks
Change in BMI in kg/m2 compared to baseline
Time frame: 13 weeks
Change in waist circumference in inches compared to baseline
Time frame: 13 weeks
Change in Total Cholesterol in mg/dl compared to baseline
Time frame: 13 weeks
Change in LDL-Cholesterol in mg/dl compared to baseline
Time frame: 13 weeks
Change in oxidized LDL-Cholesterol in mg/dl compared to baseline
Time frame: 13 weeks
Change in HDL-Cholesterol in mg/dl compared to baseline
Time frame: 13 weeks
Change in Triglycerides in mg/dl compared to baseline
Time frame: 13 weeks
Change in fasting glucose in mg/dl compared to baseline
Time frame: 13 weeks
Change in fasting Insulin in mIU/l compared to baseline
Time frame: 13 weeks
Change in Hemoglobin A1c in percentage in mIU/l compared to baseline
Time frame: 13 weeks
Change in Metabolic Syndrome Score compared to baseline
Time frame: 13 weeks
Change in Framingham Risk Assessment Score compared to baseline
Time frame: 13 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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Joseph J Lamb, MD principal investigator
Hughes Center for Research and Innovation
Questions about this trial
What is this clinical trial studying?
A study testing PROG2 in people with Obesity, run by Nature's Sunshine Products, Inc..
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 11 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". (time frame: 13 weeks). 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 4 Apr 2017.