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

NCT03098056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-04-04

No results posted yet for this study

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

Interventions

OTHER

PROG2

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

Sponsors & Collaborators

  • Nature's Sunshine Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph J Lamb, MD · Hughes Center for Research and Innovation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2016-11-18
Completion
2016-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098056 on ClinicalTrials.gov