PrediabetesNCT06376890
Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico
A study testing Red chili peppers and Green Chili Pepper in people with Prediabetes, run by New Mexico State University.
Trial summary
Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. 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?
- Red chili peppers and Green Chili Pepper
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2025
- 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
- Must be eighteen years or older,
- Fasting blood glucose of 100mg/dl to 125mg/dl
- BMI of 24 or higher
- Must be willing to ingest powdered chili pepper
- Must be able to swallow tablets
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
- History of metabolic disease
- Allergic to chili peppers
- Pregnant
Trial locations and contacts
No sites are listed yet.
David Castillo, M.S. contact
About this study
Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression.
- Conditions
- Prediabetes
- Being tested
- Red chili peppers, Green Chili Pepper, 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.
Red chili peppersDietary supplement
2.4 grams/day of powdered red chili pepper
Green Chili PepperDietary supplement
2.4 grams/day of powdered green chili peppers
PlaceboDietary supplement
2.4 grams of a metabolically equivalent placebo
| Study group | Role | What they receive |
|---|---|---|
| Red Chili Pepper | Experimental | 2.4 grams/day of red chili will be given to the red chili group for 10 weeks. Receives: Dietary Supplement: Red chili peppers |
| Green Chili Pepper | Experimental | 2.4 grams/day of green chili will be given to the green chili group for 10 weeks. Receives: Dietary Supplement: Green Chili Pepper |
| Placebo | Placebo comparator | 2.4 grams/day of corn start will be given to the placebo group for 10 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of resting and fasted blood glucose measured in mg/dl
Resting and fasted blood glucose will be measure at the pre- and post 10-week intervention time points. The outcome will be reported in mg/dl.
Measured: 10 Weeks
Concentration of resting and fasted insulin measured in pmol/L
Resting and fasted blood glucose will be measure at the pre- and post 10-week intervention time points. The outcome will be reported in pmol/L
Measured: 10 Weeks
Concentration of circulating C-reactive protein reported as mg/dl.
Circulating concentrations of C-reactive protein (CRP) will be measured pre and post intervention and will be used as an indicator of whole-body inflammation. C-reactive protein will be reported in mg/dl.
Measured: 10 weeks
Concentration of circulating interleukin (IL)-1 beta reported as pg/ml.
Circulating concentrations of IL-1 beta will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. IL-1 beta will be reported in pg/ml.
Measured: 10 weeks
Concentration of circulating interleukin-6 (IL-6) reported as pg/ml.
Circulating concentrations of IL-6 will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. IL-6 will be reported in pg/ml.
Measured: 10 weeks
Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml.
Circulating concentrations of TNF-alpha will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. TNF-alpha will be reported in pg/ml.
Measured: 10 weeks
Secondary outcomes (3)
Concentration of circulating superoxide dismutase (SOD) reported as ng/ml.
Circulating concentrations super oxide dismutase will help to identify the effects of chili peppers on free radicals circulating in the body. SOD will be reported as ng/ml.
Measured: 10 weeks
Concentration of circulating glutathione peroxidase reported as pg/ml.
Circulating concentrations glutathione peroxidase will help to identify the effects of chili peppers on free radicals circulating in the body. SOD will be reported as pg/ml.
Measured: 10 weeks
Body composition measured as total fat mass and total fat free mass reported in kg.
Total fat mass and fat free mass will be measure in grams using the air displacement method. Body composition measured as total fat free and fat mass (kg) will help to understand if chili peppers have the ability to reduce total fat mass. Being overweight or obese is a contributor to metabolic diseases like diabetes and prediabetes.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startJul 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3x2 model with 2 intervention groups (green and red chili) and a control group, and pre and post-intervention measures will be taken.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Mexico State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Smoak, New Mexico State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376890
- Sponsor's protocol ID
- Chile24
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individualized participant data will not be shared with anyone other than those on the research team.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico
- ClinicalTrials.gov ID
- NCT06376890
- Acronym / sponsor ID
- Chile24
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- New Mexico State UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- 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.
Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A 3x2 model with 2 intervention groups (green and red chili) and a control group, and pre and post-intervention measures will be taken.
| Arm | Type | Receives |
|---|---|---|
| Red Chili Pepper | Experimental | Dietary Supplement: Red chili peppers2.4 grams/day of red chili will be given to the red chili group for 10 weeks. |
| Green Chili Pepper | Experimental | Dietary Supplement: Green Chili Pepper2.4 grams/day of green chili will be given to the green chili group for 10 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2.4 grams/day of corn start will be given to the placebo group for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be eighteen years or older,
- Fasting blood glucose of 100mg/dl to 125mg/dl
- BMI of 24 or higher
- Must be willing to ingest powdered chili pepper
- Must be able to swallow tablets
Key exclusion criteria (5 listed)
- Insulin dependent diabetes
- Thyroid disease
- History of metabolic disease
- Allergic to chili peppers
- Pregnant
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 |
|---|---|---|
| Red chili peppers2.4 grams/day of powdered red chili pepper | Dietary supplement | Red Chili Pepper |
| Green Chili Pepper2.4 grams/day of powdered green chili peppers | Dietary supplement | Green Chili Pepper |
| Placebo2.4 grams of a metabolically equivalent placebo | Dietary supplement | Placebo |
Primary outcome
Concentration of resting and fasted blood glucose measured in mg/dl
Time frame: 10 Weeks
Resting and fasted blood glucose will be measure at the pre- and post 10-week intervention time points. The outcome will be reported in mg/dl.
Concentration of resting and fasted insulin measured in pmol/L
Time frame: 10 Weeks
Resting and fasted blood glucose will be measure at the pre- and post 10-week intervention time points. The outcome will be reported in pmol/L
Concentration of circulating C-reactive protein reported as mg/dl.
Time frame: 10 weeks
Circulating concentrations of C-reactive protein (CRP) will be measured pre and post intervention and will be used as an indicator of whole-body inflammation. C-reactive protein will be reported in mg/dl.
Concentration of circulating interleukin (IL)-1 beta reported as pg/ml.
Time frame: 10 weeks
Circulating concentrations of IL-1 beta will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. IL-1 beta will be reported in pg/ml.
Concentration of circulating interleukin-6 (IL-6) reported as pg/ml.
Time frame: 10 weeks
Circulating concentrations of IL-6 will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. IL-6 will be reported in pg/ml.
Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml.
Time frame: 10 weeks
Circulating concentrations of TNF-alpha will be measured pre and post intervention and will be used as an indicator of inflammation and disease progression. TNF-alpha will be reported in pg/ml.
3 secondary outcomes
Concentration of circulating superoxide dismutase (SOD) reported as ng/ml.
Time frame: 10 weeks
Concentration of circulating glutathione peroxidase reported as pg/ml.
Time frame: 10 weeks
Body composition measured as total fat mass and total fat free mass reported in kg.
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No. Individualized participant data will not be shared with anyone other than those on the research team.
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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.
David Castillo, M.S. contact
Questions about this trial
What is this clinical trial studying?
A study testing Red chili peppers and Green Chili Pepper in people with Prediabetes, run by New Mexico State University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Smoak, Ph.D. (3372541410, petersmoak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of resting and fasted blood glucose measured in mg/dl (time frame: 10 Weeks). The study lists 6 primary outcomes in all. 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 19 Apr 2024.