Clinical trial NCT05887050: Effects of a Dietary Supplement Containing Salacia Extract, Citrus Bioflavonoids, and Trivalent Chromium on Markers of Glucose Control
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose kinetics
timeFrame: Change from baseline to 12 weeks.
measure: Insulin kinetics
timeFrame: Change from baseline to 12 weeks.
Secondary outcomes:
measure: Hemoglobin A1c (HgA1c)
timeFrame: Change from baseline to 12 weeks.
measure: C-reactive protein
timeFrame: Change from baseline to 12 weeks.
measure: Adiponectin
timeFrame: Change from baseline to 12 weeks.
measure: Ferritin
timeFrame: Change from baseline to 12 weeks.
measure: Appetite
timeFrame: Change from baseline to 12 weeks.
measure: Satiety
timeFrame: Change from baseline to 12 weeks.
measure: Food cravings
timeFrame: Change from baseline to 12 weeks.
measure: Sweet food cravings
timeFrame: Change from baseline to 12 weeks.
measure: Blood urea nitrogen to creatinine ratio
timeFrame: Change from baseline to 12 weeks.
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References: