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

April 16, 2024 updated by: Peter Smoak, New Mexico State University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Red Chili Pepper
2.4 grams/day of red chili will be given to the red chili group for 10 weeks.
Dietary supplement: Red chili peppers
2.4 grams/day of powdered red chili pepper
Experimental: Green Chili Pepper
2.4 grams/day of green chili will be given to the green chili group for 10 weeks.
Dietary supplement: Green Chili Pepper
2.4 grams/day of powdered green chili peppers
Placebo Comparator: Placebo
2.4 grams/day of corn start will be given to the placebo group for 10 weeks.
Dietary supplement: Placebo
2.4 grams of a metabolically equivalent placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 Weeks
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
10 Weeks
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.
10 weeks
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.
10 weeks
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.
10 weeks
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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of circulating superoxide dismutase (SOD) reported as ng/ml.
Time Frame: 10 weeks
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
Concentration of circulating glutathione peroxidase reported as pg/ml.
Time Frame: 10 weeks
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
Body composition measured as total fat mass and total fat free mass reported in kg.
Time Frame: 10 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Mexico State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chile24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individualized participant data will not be shared with anyone other than those on the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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