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OpenTrials
Completed

NCT Number: NCT05573607

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

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.

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

Maltodextrin tablet

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)

Primary outcomes

  1. glucose

    Time frame: change from baseline to week 12

    measurement of glucose in blood

  2. insulin

    Time frame: change from baseline to week 12

    measurement of insulin in blood

Secondary outcomes

  1. cravings

    Time frame: change from baseline to week 12

    cravings as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.

  2. satiety

    Time frame: change from baseline to week 12

    satiety as measured with a 10 cm anchored visual analogue scale, where higher values represent greater cravings.

  3. adiponectin

    Time frame: change from baseline to week 12

    measurement of adiponectin in blood

  4. blood urea nitrogen

    Time frame: change from baseline to week 12

    measurement of blood urea nitrogen in blood

  5. creatinine

    Time frame: change from baseline to week 12

    measurement of creatinine in blood

  6. alanine aminotransferase

    Time frame: change from baseline to week 12

    measurement of alanine aminotransferase in blood

  7. aspartate aminotransferase

    Time frame: change from baseline to week 12

    measurement of aspartate aminotransferase in blood

  8. Short Form Health Survey (SF-36)

    Time frame: change from baseline to week 12

    health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.

Sponsors and collaborators

Lead sponsor

The Center for Applied Health Sciences, LLC

Industry

Collaborators

  • Keller Consulting Group
  • Mend Nutrition, Inc

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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