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Glucose IntoleranceNCT05887050

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

A study testing Active in people with Glucose Intolerance, run by The Center for Applied Health Sciences, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Glucose Intolerance
What is being tested?
Active
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
3 Dec 2020to 20 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Center for Applied Health Sciences

    Canfield, Ohio, 44406

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Active, Placebo
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActiveDietary supplement

    Blend of chromium, amla fruit extract, and citrus bioflavonoids

  • PlaceboDietary supplement

    Maltodextrin tablet

Study groups in NCT05887050
Study groupRoleWhat they receive
ActiveActive comparatorTablet 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)
Receives: Dietary Supplement: Active
PlaceboPlacebo comparatorIdentical size, shape, and weight maltodextrin tablet
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose kinetics

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

    Measured: Change from baseline to 12 weeks.

  2. Insulin kinetics

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

    Measured: Change from baseline to 12 weeks.

Secondary outcomes (9)

  1. Hemoglobin A1c (HgA1c)

    Serum HgA1c

    Measured: Change from baseline to 12 weeks.

  2. C-reactive protein

    Serum C-reactive protein

    Measured: Change from baseline to 12 weeks.

  3. Adiponectin

    Serum adiponectin

    Measured: Change from baseline to 12 weeks.

  4. Ferritin

    Serum ferritin

    Measured: Change from baseline to 12 weeks.

  5. 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.

    Measured: Change from baseline to 12 weeks.

  6. 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.

    Measured: Change from baseline to 12 weeks.

  7. 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.

    Measured: Change from baseline to 12 weeks.

  8. 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.

    Measured: Change from baseline to 12 weeks.

  9. Blood urea nitrogen to creatinine ratio

    The ratio of blood urea nitrogen to creatinine in serum.

    Measured: Change from baseline to 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start3 Dec 2020
  3. Primary completion22 Jun 2021
  4. Study completion20 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05887050
Sponsor's protocol ID
MEND-2023
Status last verified
Jun 2023
First submitted
24 May 2023
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active in people with Glucose Intolerance, run by The Center for Applied Health Sciences, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucose kinetics (time frame: Change from baseline to 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05887050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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