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

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active
Placebo
Sponsored by
The Center for Applied Health Sciences, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Center for Applied Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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)

Identical size, shape, and weight maltodextrin tablet

Outcomes

Primary Outcome Measures

Glucose kinetics
Serum glucose response during a two hour oral sucrose tolerance test.
Insulin kinetics
Serum insulin response during a two hour oral sucrose tolerance test.

Secondary Outcome Measures

Hemoglobin A1c (HgA1c)
Serum HgA1c
C-reactive protein
Serum C-reactive protein
Adiponectin
Serum adiponectin
Ferritin
Serum ferritin
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.
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.
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.
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.
Blood urea nitrogen to creatinine ratio
The ratio of blood urea nitrogen to creatinine in serum.

Full Information

First Posted
May 24, 2023
Last Updated
June 1, 2023
Sponsor
The Center for Applied Health Sciences, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05887050
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Center for Applied Health Sciences, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical size, shape, and weight maltodextrin tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Active
Intervention Description
Blend of chromium, amla fruit extract, and citrus bioflavonoids
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin tablet
Primary Outcome Measure Information:
Title
Glucose kinetics
Description
Serum glucose response during a two hour oral sucrose tolerance test.
Time Frame
Change from baseline to 12 weeks.
Title
Insulin kinetics
Description
Serum insulin response during a two hour oral sucrose tolerance test.
Time Frame
Change from baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Hemoglobin A1c (HgA1c)
Description
Serum HgA1c
Time Frame
Change from baseline to 12 weeks.
Title
C-reactive protein
Description
Serum C-reactive protein
Time Frame
Change from baseline to 12 weeks.
Title
Adiponectin
Description
Serum adiponectin
Time Frame
Change from baseline to 12 weeks.
Title
Ferritin
Description
Serum ferritin
Time Frame
Change from baseline to 12 weeks.
Title
Appetite
Description
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.
Time Frame
Change from baseline to 12 weeks.
Title
Satiety
Description
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.
Time Frame
Change from baseline to 12 weeks.
Title
Food cravings
Description
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.
Time Frame
Change from baseline to 12 weeks.
Title
Sweet food cravings
Description
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.
Time Frame
Change from baseline to 12 weeks.
Title
Blood urea nitrogen to creatinine ratio
Description
The ratio of blood urea nitrogen to creatinine in serum.
Time Frame
Change from baseline to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The Center for Applied Health Sciences
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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