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

NCT ID: NCT06376890

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Red Chili Pepper

2.4 grams/day of red chili will be given to the red chili group for 10 weeks.

Group Type EXPERIMENTAL

Red chili peppers

Intervention Type DIETARY_SUPPLEMENT

2.4 grams/day of powdered red chili pepper

Green Chili Pepper

2.4 grams/day of green chili will be given to the green chili group for 10 weeks.

Group Type EXPERIMENTAL

Green Chili Pepper

Intervention Type DIETARY_SUPPLEMENT

2.4 grams/day of powdered green chili peppers

Placebo

2.4 grams/day of corn start will be given to the placebo group for 10 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2.4 grams of a metabolically equivalent placebo

Interventions

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Red chili peppers

2.4 grams/day of powdered red chili pepper

Intervention Type DIETARY_SUPPLEMENT

Green Chili Pepper

2.4 grams/day of powdered green chili peppers

Intervention Type DIETARY_SUPPLEMENT

Placebo

2.4 grams of a metabolically equivalent placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New Mexico State University

OTHER

Sponsor Role lead

Responsible Party

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Peter Smoak

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Peter Smoak, Ph.D.

Role: CONTACT

3372541410

David Castillo, M.S.

Role: CONTACT

Other Identifiers

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Chile24

Identifier Type: -

Identifier Source: org_study_id

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