Impact of Chromium, Phyllanthus Emblica, and Shilajit on Cardiovascular Health, Fitness, and Weight Loss During Exercise and Diet Programs
NCT06641596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2024-10-15
Summary
A randomized, double-blind, placebo controlled, parallel study to determine if Chromium (Cr), Phyllanthus emblica (PE) and Shilajit (SJ) supplementation and Phyllanthus emblica fruit extract supplementation promotes greater changes in glucose homeostasis, endothelial function, and cardiometabolic risk in sedentary and overweight men and women initiating an exercise and weight loss program.
Conditions
- Overweight
- Metabolic Syndrome X
Interventions
- DIETARY_SUPPLEMENT
-
Placebo
2 capsules of Placebo, once daily after breakfast for 12 weeks
- DIETARY_SUPPLEMENT
-
Cr-400
1 capsule of Cr-400 + 1 capsule of Placebo, once a day after breakfast for 12 weeks
- DIETARY_SUPPLEMENT
-
Cr-800
2 capsules of Cr-400, once a day after breakfast for 12 weeks
- DIETARY_SUPPLEMENT
-
PE-500
1 capsule of PE + 1 capsule of Placebo, once a day after breakfast for 12 weeks
- DIETARY_SUPPLEMENT
-
PE-1000
2 capsules of PE-500, once a day after breakfast for 12 weeks
Sponsors & Collaborators
-
Kerry Group P.L.C
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-01
- Primary Completion
- 2024-01-30
- Completion
- 2024-05-29
Countries
- United States
Study Locations
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