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临床试验/NCT06674642
NCT06674642已完成不适用

Traditional Indigenous Foods Diet and Health Study

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Change in physical activity as measured by Accelerometer

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Change in physical activity as measured by Accelerometer

时间窗: Day 0, Day 7

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

次要结局

未报告次要终点

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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