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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376890
• Other study ID #: Chile24
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: New Mexico State University
• Contact: Peter Smoak, Ph.D.
• Phone: 3372541410
• Email: petersmoak[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Prediabetes

Intervention

Dietary Supplement:
• Red chili peppers
2.4 grams/day of powdered red chili pepper
• Green Chili Pepper
2.4 grams/day of powdered green chili peppers
• Placebo
2.4 grams of a metabolically equivalent placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 Weeks
Primary	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	10 Weeks
Primary	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.	10 weeks
Primary	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.	10 weeks
Primary	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.	10 weeks
Primary	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.	10 weeks
Secondary	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.	10 weeks
Secondary	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.	10 weeks
Secondary	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.	10 weeks