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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05887050
Other study ID # MEND-2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2020
Est. completion date July 20, 2021

Study information

Verified date June 2023
Source The Center for Applied Health Sciences, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study was a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women 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), NMR profile, 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 (see Study Schematic for details). Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date July 20, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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 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 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Active
Blend of chromium, amla fruit extract, and citrus bioflavonoids
Placebo
Maltodextrin tablet

Locations

Country Name City State
United States The Center for Applied Health Sciences Canfield Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Center for Applied Health Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose kinetics Serum glucose response during a two hour oral sucrose tolerance test. Change from baseline to 12 weeks.
Primary Insulin kinetics Serum insulin response during a two hour oral sucrose tolerance test. Change from baseline to 12 weeks.
Secondary Hemoglobin A1c (HgA1c) Serum HgA1c Change from baseline to 12 weeks.
Secondary C-reactive protein Serum C-reactive protein Change from baseline to 12 weeks.
Secondary Adiponectin Serum adiponectin Change from baseline to 12 weeks.
Secondary Ferritin Serum ferritin Change from baseline to 12 weeks.
Secondary Appetite Appetite as measured by a 10 cm visual analogue scale, where higher values represent greater appetite. Values range from 1-10, and a greater appetite score would be a worse outcome in these participants. Change from baseline to 12 weeks.
Secondary Satiety Satiety as measured by a 10 cm visual analogue scale, where higher values represent greater satiety. Values range from 1-10, and a greater satiety score would be a better outcome in these participants. Change from baseline to 12 weeks.
Secondary Food cravings Food cravings as measured by a 10 cm visual analogue scale, where higher values represent greater food cravings. Values range from 1-10, and a greater food cravings score would be a worse outcome in these participants. Change from baseline to 12 weeks.
Secondary Sweet food cravings Sweet food cravings as measured by a 10 cm visual analogue scale, where higher values represent greater sweet food cravings. Values range from 1-10, and a greater sweet food cravings score would be a worse outcome in these participants. Change from baseline to 12 weeks.
Secondary Blood urea nitrogen to creatinine ratio The ratio of blood urea nitrogen to creatinine in serum. Change from baseline to 12 weeks.
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