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Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico

Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06376890
Enrollment
21
Registered
2024-04-19
Start date
2024-07-31
Completion date
2025-07-31
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTRed chili peppers

2.4 grams/day of powdered red chili pepper

DIETARY_SUPPLEMENTGreen Chili Pepper

2.4 grams/day of powdered green chili peppers

DIETARY_SUPPLEMENTPlacebo

2.4 grams of a metabolically equivalent placebo

Sponsors

New Mexico State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Only the primary investigator will know the intervention assigned to the participants.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Insulin dependent diabetes * Thyroid disease * History of metabolic disease * Allergic to chili peppers * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml.10 weeksCirculating 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.
Concentration of circulating C-reactive protein reported as mg/dl.10 weeksCirculating 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.10 weeksCirculating 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.10 weeksCirculating 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 resting and fasted blood glucose measured in mg/dl10 WeeksResting 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/L10 WeeksResting 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

Secondary

MeasureTime frameDescription
Concentration of circulating glutathione peroxidase reported as pg/ml.10 weeksCirculating 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.
Body composition measured as total fat mass and total fat free mass reported in kg.10 weeksTotal 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.
Concentration of circulating superoxide dismutase (SOD) reported as ng/ml.10 weeksCirculating 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.

Contacts

Primary ContactPeter Smoak, Ph.D.
petersmoak@gmail.com3372541410
Backup ContactDavid Castillo, M.S.
dcastil@nmsu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026