Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control

NCT05887050 | Completed

• 1 other identifier: MEND-2023
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a double-blind, randomized, placebo-controlled, clinical trial with two parallel groups. Participants reported to a single investigational center in Ohio (i.e., The Center for Applied Health Sciences) during the 12 week trial.

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (2)

• Glucose kinetics

  Serum glucose response during a two hour oral sucrose tolerance test.

  Change from baseline to 12 weeks.

• Insulin kinetics

  Serum insulin response during a two hour oral sucrose tolerance test.

  Change from baseline to 12 weeks.

Secondary Outcomes (9)

• Hemoglobin A1c (HgA1c)

  Change from baseline to 12 weeks.

• C-reactive protein

  Change from baseline to 12 weeks.

• Adiponectin

  Change from baseline to 12 weeks.

• Ferritin

  Change from baseline to 12 weeks.

• Appetite

  Change from baseline to 12 weeks.

Study Arms (2)

Active

ACTIVE COMPARATOR

Tablet containing 400 mcg chromium (delivered as Crominex® 3+, a blend of chromium, Capros® Amla Extract (Fruit), PrimaVie® Shilajit), and 325 mg of MetaviveTM complex (Salacia Chinensis Extract (Fruit) and a Citrus Bioflavonoid Complex)

Dietary Supplement: Active

Placebo

PLACEBO COMPARATOR

Identical size, shape, and weight maltodextrin tablet

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

Blend of chromium, amla fruit extract, and citrus bioflavonoids

Active

Placebo DIETARY_SUPPLEMENT

Maltodextrin tablet

Placebo

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 blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
• Normal seated, resting heart rate (\<90 per minute).
• Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise

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

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Supplements were blinded by the sponsor prior to initiation of any research activities. All research activities, including statistical analysis, were completed by the research team while blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants were randomly assigned to receive either the active product or a placebo. Subjects were instructed to consume their respective supplement daily for 12 weeks, approximately 15-30 minutes prior to their evening meal.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: December 3, 2020
• Primary Completion: June 22, 2021
• Study Completion: July 20, 2021
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)