PrediabetesNCT02146157
Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
A study testing herb and mineral combination product in people with Prediabetes, run by NewChapter, Inc. at 6 sites in United States.
Trial summary
This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- herb and mineral combination product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2013to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be male or female, at least 18 years of age
- If age ≥45 years, must have a body mass index ≥ 25 kg/m2
- If age <45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
- Be able to understand the nature and purpose of the study including potential risks and side effects
- Be willing to consent to study participation and to comply with study requirements
- Have a finger stick fasting blood glucose between 105 and 140 mg/dL and a serum fasting glucose between 100 and 125 mg/dL, measured at screening
Who cannot join
- Have diabetes (type I or II) or an HBA1c measurement >6.5% at any time in the past or at the screening visit
- Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
- Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
- Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
- Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
Show all 13Show fewer
- Eating disorder
- Polycystic ovary syndrome
- Known allergies or intolerance to any substance in the study product
- Are pregnant or breastfeeding women
- History of alcohol, drug, or medication abuse
- Have participated in another study with any investigational product within 1 month of screening
- Had a recent (<3 months) gastrointestinal surgery or any planned surgery during the clinical study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Quest Research Institute
Bingham Farms, Michigan, 48025
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Cincinnati, Ohio, 45249
Providence Health Partners Center for Clinical Research
Dayton, Ohio, 45439
Mountain View Clinical Research
Greer, South Carolina, 29651
Central Kentucky Research Associates
Lexington, Kentucky, 40509
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Assess Efficacy and Tolerability of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.
Read the detailed description
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
- Conditions
- Prediabetes
- Being tested
- herb and mineral combination product, Placebo
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herb and mineral combination productDietary supplement
herb and mineral product containing cinnamon, turmeric and holy basil
PlaceboDietary supplement
Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
| Study group | Role | What they receive |
|---|---|---|
| herb and mineral combination product | Active comparator | Subjects will consume 3 herb and mineral combination product softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period. Receives: Dietary Supplement: herb and mineral combination product |
| placebo | Placebo comparator | Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in fasting blood glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
Measured: Day 84
Secondary outcomes (8)
Change from Baseline in fasting serum glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42
Measured: Day 42
Change from Baseline in fasting blood glucose
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
Measured: Day 21
Change from Baseline in HbA1c
Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
Measured: Day 84
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 84 using a standard lipid panel.
Measured: Day 84
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 42 using a standard lipid panel.
Measured: Day 42
Change from Baseline in fasting lipids
Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 21 using a standard lipid panel.
Measured: Day 21
Change from Baseline in BMI
Body mass index
Measured: Day 84
Change from Baseline in waist-to-hip ratio
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewChapter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146157
- Sponsor's protocol ID
- 2012110
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial to Assess Efficacy and Tolerability of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
- ClinicalTrials.gov ID
- NCT02146157
- Acronym / sponsor ID
- 2012110
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- NewChapter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.
Detailed description
The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herb and mineral combination product | Active comparator | Dietary Supplement: herb and mineral combination productSubjects will consume 3 herb and mineral combination product softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be male or female, at least 18 years of age
- If age ≥45 years, must have a body mass index ≥ 25 kg/m2
- If age <45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
- Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
- Be able to understand the nature and purpose of the study including potential risks and side effects
Key exclusion criteria (13 listed)
- Have diabetes (type I or II) or an HBA1c measurement >6.5% at any time in the past or at the screening visit
- Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
- Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
- Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herb and mineral combination productherb and mineral product containing cinnamon, turmeric and holy basil | Dietary supplement | herb and mineral combination product |
| PlaceboPlacebo of herb and mineral product containing cinnamon, turmeric and holy basil | Dietary supplement | placebo |
Primary outcome
Change from Baseline in fasting blood glucose
Time frame: Day 84
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
8 secondary outcomes
Change from Baseline in fasting serum glucose
Time frame: Day 42
Change from Baseline in fasting blood glucose
Time frame: Day 21
Change from Baseline in HbA1c
Time frame: Day 84
Change from Baseline in fasting lipids
Time frame: Day 84
Change from Baseline in fasting lipids
Time frame: Day 42
Change from Baseline in fasting lipids
Time frame: Day 21
Change from Baseline in BMI
Time frame: Day 84
Change from Baseline in waist-to-hip ratio
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herb and mineral combination product in people with Prediabetes, run by NewChapter, Inc. at 6 sites 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 7 inclusion and 13 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Change from Baseline in fasting blood glucose (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.