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临床试验/NCT06758869
NCT06758869尚未招募不适用

Effects of Daily Consumption of Processed Pulse-based Food Products on Physiological Responses Related to Energy Metabolism and Metabolic Health

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
204
试验地点
2
主要终点
Differences in substrate oxidation in response to eating differentially processed pulse-based food products

研究概览

简要总结

The purpose of this research is to test how processing can affect how one's body uses the nutrients in that food. For this study the researchers are examining how making different food products out of chickpeas, such as hummus or pasta, changes how one's body uses those foods for energy.

详细描述

The overall objective is to determine the impact of daily consumption of processed pulse-based food products on metabolic health, specifically the physiological responses related to energy metabolism. The primary hypothesis is that consuming a serving of pulses daily for 12 weeks will improve metabolic responses related to energy metabolism, particularly fat oxidation and molecular adaptations related to fat and glucose metabolism, compared to current Dietary Guidelines for Americans (DGA) recommendations. Furthermore, we hypothesize that the degree of processing will influence these metabolic adaptations such that the daily consumption of 100% pulse flour food products will result in the greatest effect on fat oxidation and molecular adaptations related to fat and glucose metabolism followed by the pulse purée which will have a greater effect than the whole cooked pulse (100% pulse flour > purée > whole).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • apparently healthy adults
  • BMI >18.5 or <35 kg/m2 (healthy body weight - class I obesity)
  • ability to understand and sign the consent form
  • availability of transportation (i.e., participants must provide their own transportation to the Center)
  • non-smoking or do not use other tobacco products, including e-cigarettes
  • not taking steroid-based medications
  • not planning to or currently attempting to gain or lose weight
  • not allergic to study foods
  • willing to comply with study demands

排除标准

  • usual pulse consumption greater than DGA recommendation
  • inability or unwillingness to consume any of the provided foods
  • more than a 10% change in body weight within the past 2 months
  • actively trying to lose weight
  • pregnancy or actively trying to get pregnant
  • lactation
  • uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
  • diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
  • HbA1c ≥ 5.7%
  • complete blood count (CBC) outside of the normal range for a healthy adult
  • history of gastrointestinal (GI) disorders (including Celiac's or Crohn's disease, irritable bowel syndrome, acid reflux, ulcerative colitis, chronic constipation or diarrhea, and lactose intolerance)
  • using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids)
  • cannot read or understand English

研究组 & 干预措施

Control

Experimental

Base DGA diet with a standardized non-pulse product snack

干预措施: Control (Other)

Whole Chickpeas

Experimental

Adjusted DGA diet with standardized whole chickpea snack

干预措施: Whole Chickpeas (Other)

Puréed Chickpeas

Experimental

Adjusted DGA diet with standardized puréed chickpea snack

干预措施: Puréed Chickpeas (Other)

100% Chickpea Flour Product

Experimental

Adjusted DGA diet with standardized 100% chickpea flour product snack

干预措施: 100% Chickpea Flour Product (Other)

结局指标

主要结局

Differences in substrate oxidation in response to eating differentially processed pulse-based food products

时间窗: 12 weels

Using whole-room calorimetry, measure differences in fat, carbohydrate, and protein oxidation in response to daily consumption of whole chickpeas, pureed chickpeas, or chickpea-flour pasta compared to a control diet.

Change from Baseline in substrate oxidation after consuming differentially processed pulse-based food products for 12 weeks

时间窗: 12 weeks

Measure changes in fat, carbohydrate, and protein oxidation in response to consuming whole chickpeas, pureed chickpeas, or chickpea-flour pasta using whole room calorimetry

Determine participant consumption practices and attitudes towards pulse consumption using a validated questionnaire

时间窗: Baseline

The questionnaire is designed to assess enjoyment (two items), sensory properties (eight items), perceived cooking abilities (ten items), perceived practical aspects (six items), perceived healthiness (two items), upbringing (two items), social influences (four items), and quality issues (six items) of pulse consumption.

次要结局

  • Changes in the colonic microbiota in response to consuming differentially processed pulse-based food products(12 weeks)
  • Changes in me metabolic gene expression and metabolites in response to consuming differentially processed pulse-based food products.(12 weeks)

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Shanon Casperson

Research Biologist

USDA Grand Forks Human Nutrition Research Center

研究点 (2)

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