Traditional Indigenous Foods Diet and Health Study

NCT06674642 | Completed

• 1 other identifier: GFHNRC157
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Behavior; Physical Activity

Keywords

Traditional Indigenous foods diet; American Indians

Outcome Measures

Primary Outcomes (1)

• Change in physical activity as measured by Accelerometer

  Activity will be measured by an accelerometer for seven days in each phase

  Day 0, Day 7

Study Arms (1)

Traditional Indigenous Foods diet

EXPERIMENTAL

Participants will consume a diet comprised of traditional indigenous foods.

Other: Traditional Indigenous Foods diet

Interventions

Traditional Indigenous Foods diet OTHER

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

Traditional Indigenous Foods diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• USDA Grand Forks Human Nutrition Research Center: lead

Study Sites (1)

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58203, United States

Location

Related Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julie Hess, PhD

  USDA Grand Forks Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study will employ a single-subject experiment (personalized trial) approach with an ABAB design. The participants will act as their own controls. During Phase A participants will consume their usual (control) diet. During Phase B they will consume a Traditional Indigenous Foods diet provided by the GFHNRC. Randomization in single-subject designs takes the form of random assignment of treatment start times and phase lengths for each participant. Statistical analysis will consist of a mixed model that will be fit with a fixed effect of phase (A1, B1, A2, B2) and random intercept for subject for the for each item being examined.

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: September 12, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)