Traditional Indigenous Foods Diet and Health Study

NCT ID: NCT06674642

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-12
• Study Completion Date: 2025-04-07

Brief Summary

The purpose of this research is to determine whether eating a diet made up of Traditional Indigenous Foods from the Northern Great Plains area will spontaneously result in an increase in physical activity by American Indians, and whether the diet improves metabolic measures of health, mood and self-regulation of healthy eating and engaging in physical activity.

Detailed Description

The primary aim of the current study is to determine whether consuming a healthier more Traditional Indigenous Foods diet produces non-targeted simultaneous changes in physical activity of American Indians. Coaction or dual behavior change refers to a spontaneous change in a nontargeted behavior when producing a change in a targeted behavior. A benefit of coactivation is that two healthy behaviors change when targeting just one. Physical activity was chosen as a primary non-targeted behavior because American Indians and Alaska Natives are 34% more likely to report physical inactivity than non-Hispanic Whites. Physical inactivity and sedentary behavior have negative health consequences. Chronic health conditions such as obesity, cardiovascular disease, Type 2 diabetes, and mental health disorders are more prevalent in people who are physically inactive and/or engage in greater sedentary behavior. A unique aspect of the proposed research is that it will develop a traditional indigenous foods diet based on historical research of several tribes (Mandan, Hidatsa, and Arikara (MHA) Nation, Lakota Sioux, Western and Eastern Dakota Sioux, Ojibwa, and Chippewa tribes) that lived in the Northern Great Plains. The nutrient content of the diet will be based on the 2020 Dietary Guidelines for Americans (DGA) Healthy U.S.-Style Dietary Pattern. However, because bovine dairy is not native to the U.S., alternative foods will be used to ensure adequate intake of the nutrients commonly provided by the dairy food groups. Calcium concentration of participants will be carefully monitored. This study will use a personalized trial approach that focuses on understanding individual responses of American Indians living with a heritage from the Northern Great Plains to a Traditional Indigenous Foods diet on behavioral, psychological, and clinical biochemistry outcomes.

Conditions

Sedentary Behavior; Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Traditional Indigenous Foods diet

Participants will consume a diet comprised of traditional indigenous foods.

Group Type: EXPERIMENTAL

Traditional Indigenous Foods diet

Intervention Type: OTHER

A diet composed of traditional indigenous foods will be given to participants.

Interventions

Traditional Indigenous Foods diet

A diet composed of traditional indigenous foods will be given to participants.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• American Indian
• Body mass index (BMI) of 18.5-42.0 kg/m2

Exclusion Criteria

• Health condition that impairs mobility or ability to safely be physically active
• Fasting Blood glucose ≥ 126 mg/dl
• Currently taking anti-inflammatory medications
• Pregnant, breast feeding or lactating
• Currently on a regulated diet
• Currently exercising for 60 minutes or longer greater than 2 times per week
• Allergic to any of the study foods shown in the menu and list of ingredients
• Strong aversion to any of the study foods
• Taking one of the following medications: blood thinning drugs, insulin, biologics, chemotherapy or on immune suppressant medications, and those who have started a new hyperglycemic, hypercholesterolemia, anti-depressant, anti-anxiety, or anti-psychotic medication(s) in the last two months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Hess, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/

Grand Forks Human Nutrition Research Center Current Nutrition Studies

Other Identifiers

GFHNRC157

Identifier Type: -

Identifier Source: org_study_id