Effects of a Dietary Supplement on Markers of Glucose Control and Quality of Life

NCT05573607 | Completed

• 1 other identifier: 25-CAHS-104
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health Sciences). Subjects will attend four study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work \[also HgA1c, insulin\], background baseline diet). Over the next 12 weeks, subjects will attend Visits 2-4, wherein assessments of serum glucose, insulin, HOMA-IR, 2-hour glucose tolerance test (GTT), HgA1c, C-reactive protein, adiponectin, ferritin, waist circumference, quality of life questionnaire, and various visual analog scales for appetite, satiety, and cravings will be made.

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (2)

• glucose

  measurement of glucose in blood

  change from baseline to week 12

• insulin

  measurement of insulin in blood

  change from baseline to week 12

Secondary Outcomes (8)

• cravings

  change from baseline to week 12

• satiety

  change from baseline to week 12

• adiponectin

  change from baseline to week 12

• blood urea nitrogen

  change from baseline to week 12

• creatinine

  change from baseline to week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Consists of a maltodextrin tablet

Dietary Supplement: Placebo

Active

ACTIVE COMPARATOR

A tablet consisting of a blend of Crominex® 3+, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoids)

Dietary Supplement: Chromium

Interventions

Placebo DIETARY_SUPPLEMENT

Maltodextrin tablet

Placebo

Chromium DIETARY_SUPPLEMENT

A tablet consisting of a blend of Crominex® 3+, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoids)

Active

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary signed and dated informed consent. Be in good health as determined by medical history and routine blood chemistries.
• Age between the ages of 21 and 65 (inclusive). Body Mass Index of 18.5-34.99 (inclusive). Body weight of at least 120 pounds. Fasting blood sugar of 100-125 (inclusive) OR HgA1c of 5.7-6.4% (inclusive). Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic bloodpressure \< 90 mm Hg.
• Normal seated, resting heart rate (\<90 per minute). Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise for 24 hr prior to each trial, and fast for 10 hours prior each of the treatments.

You may not qualify if:

• History of unstable or new-onset cardiovascular or cardiorespiratory disease. History of diabetes, or other endocrine disorder. Fasting blood sugar of \> 125 mg/dL or HgA1c of \> 6.4%. History of use of medications or dietary supplements known to affect glycemia or insulinemia.
• History of hyperparathyroidism or an untreated thyroid disease. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
• Prior gastrointestinal bypass surgery (Lapband), etc. Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
• Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
• Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of- Analysis.
• Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
• Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Mend Nutrition, Inc: collaborator
• Keller Consulting Group: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Interventions

Chromium

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: November 19, 2020
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

US (1)