Clinical trial NCT06376890: Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico
Official title: Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prediabetes
Lead sponsor: New Mexico State University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Concentration of resting and fasted blood glucose measured in mg/dl
timeFrame: 10 Weeks
measure: Concentration of resting and fasted insulin measured in pmol/L
timeFrame: 10 Weeks
measure: Concentration of circulating C-reactive protein reported as mg/dl.
timeFrame: 10 weeks
measure: Concentration of circulating interleukin (IL)-1 beta reported as pg/ml.
timeFrame: 10 weeks
measure: Concentration of circulating interleukin-6 (IL-6) reported as pg/ml.
timeFrame: 10 weeks
measure: Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml.
timeFrame: 10 weeks
Secondary outcomes:
measure: Concentration of circulating superoxide dismutase (SOD) reported as ng/ml.
timeFrame: 10 weeks
measure: Concentration of circulating glutathione peroxidase reported as pg/ml.
timeFrame: 10 weeks
measure: Body composition measured as total fat mass and total fat free mass reported in kg.
timeFrame: 10 weeks
Other outcomes:
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