Clinical trial NCT03098056: Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2
Official title: Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function - Second Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Nature's Sunshine Products, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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):
* 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.

Exclusion Criteria included:

* 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
* 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
timeFrame: 13 weeks
Secondary outcomes:
measure: Number of participants with treatment-related changes in basic safety labs
timeFrame: 13 weeks
measure: Number of participants with treatment-related changes in vital signs
timeFrame: 13 weeks
measure: Change in weight in pounds compared to baseline
timeFrame: 13 weeks
measure: Change in body fat in percentage compared to baseline
timeFrame: 13 weeks
measure: Change in BMI in kg/m2 compared to baseline
timeFrame: 13 weeks
measure: Change in waist circumference in inches compared to baseline
timeFrame: 13 weeks
measure: Change in Total Cholesterol in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in LDL-Cholesterol in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in oxidized LDL-Cholesterol in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in HDL-Cholesterol in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in Triglycerides in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in fasting glucose in mg/dl compared to baseline
timeFrame: 13 weeks
measure: Change in fasting Insulin in mIU/l compared to baseline
timeFrame: 13 weeks
measure: Change in Hemoglobin A1c in percentage in mIU/l compared to baseline
timeFrame: 13 weeks
measure: Change in Metabolic Syndrome Score compared to baseline
timeFrame: 13 weeks
measure: Change in Framingham Risk Assessment Score compared to baseline
timeFrame: 13 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hughes Center for Research and Innovation
name: Joseph J Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References: