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

Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control and Quality of Life: A Randomized, Placebo-Controlled, Double-Blind Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Chromium

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Consists of a maltodextrin tablet	Dietary supplement: Placebo; Maltodextrin tablet
ACTIVE_COMPARATOR: Active; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cravings	cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.	change from baseline to week 12
satiety	satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.	change from baseline to week 12
adiponectin	measurement of adiponectin in blood	change from baseline to week 12
blood urea nitrogen	measurement of blood urea nitrogen in blood	change from baseline to week 12
creatinine	measurement of creatinine in blood	change from baseline to week 12
alanine aminotransferase	measurement of alanine aminotransferase in blood	change from baseline to week 12
aspartate aminotransferase	measurement of aspartate aminotransferase in blood	change from baseline to week 12
Short Form Health Survey (SF-36)	health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.	change from baseline to week 12

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC
• Collaborators: Mend Nutrition, Inc; Keller Consulting Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2020
• Primary Completion (ACTUAL): July 8, 2021
• Study Completion (ACTUAL): July 8, 2021

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (ACTUAL): October 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Chromium
• Other Study ID Numbers: 25-CAHS-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No