NCT03685552

Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0

Safety Evaluation of a Diet and Nutritional Supplementation Program for Support of Balanced Bowel Function in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Nature's Sunshine Products, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The study evaluated the safety, tolerability and acceptability of a lifestyle modification program with nutritional supplementation designed to restore balance to healthy bowel function in generally healthy subjects

Detailed description

To investigate the safety, tolerance and acceptability of a lifestyle modification and targeted nutraceuticals for balanced bowel function in generally healthy volunteers. To evaluate safety and tolerability, blood samples were drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Quality of life questionnaires, medical symptom questionnaire were evaluated at baseline, week 1, week 2 and week 4. Vitals signs, weight and body composition were monitored at each visit.

Conditions

• Gastrointestinal Symptoms

Interventions

Type	Name	Description
OTHER	Prog: Purify-2	Nutritional Supplements to be administered: * Protein Shakes: one protein shake twice a day * Probiotics (Bacillus Coagulans) once a day * Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day * In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day

Timeline

• Start date: 2017-08-03
• Primary completion: 2017-09-13
• Completion: 2017-09-13
• First posted: 2018-09-26
• Last updated: 2018-09-26

Locations

1 site across 1 country: United States