Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2

NCT03098056 | Completed DMC

• 1 other identifier: NSP-CT-010
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks

Secondary Outcomes (16)

• Number of participants with treatment-related changes in basic safety labs

  13 weeks

• Number of participants with treatment-related changes in vital signs

  13 weeks

• Change in weight in pounds compared to baseline

  13 weeks

• Change in body fat in percentage compared to baseline

  13 weeks

• Change in BMI in kg/m2 compared to baseline

  13 weeks

Study Arms (1)

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.

Other: PROG2

Interventions

PROG2 OTHER

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

PROG2

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nature's Sunshine Products, Inc.: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph J Lamb, MD

  Hughes Center for Research and Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 31, 2017
• Study Start: August 1, 2016
• Primary Completion: November 18, 2016
• Study Completion: December 31, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share