The Effect of Regular Consumption of Intermediate Wheatgrass-Based Products on Measures of Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Gut Microbiome Wellness Index
研究概览
简要总结
This study will evaluate the effect of daily consumption of intermediate wheatgrass-based products on measures of gut health compared with whole wheat-based products in healthy adults with traditional western fiber intake.
Participants will first complete screening, stool sample collection, and the Diet History Questionnaire III. Participants with dietary fiber intake greater than 12g/1000 calories per day will complete the study after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will enter a randomized crossover dietary intervention.
During the intervention, participants will consume intermediate wheatgrass-based products and whole wheat-based products in randomized order. Each intervention period will last 2 weeks and will be separated by a 2-week washout period. The primary outcome is change in Gut Microbiome Wellness Index. Gastrointestinal symptom scores will also be assessed.
详细描述
Intermediate wheatgrass is a perennial grain that is high in protein, antioxidants, and fiber. This study is designed to evaluate whether regular consumption of intermediate wheatgrass-based products improves measures of gut health compared with whole wheat-based products in healthy adults consuming a traditional western fiber intake.
The study will enroll healthy adults who are willing to consume bread products daily and have regular access to a smartphone. Participants will complete a REDCap pre-screening questionnaire. Eligible participants will complete informed consent, the National Cancer Institute Diet History Questionnaire III, and baseline stool sample collection.
Participants with dietary fiber intake greater than 12g/1000 calories per day will complete participation after baseline procedures. Participants with dietary fiber intake of 12g/1000 calories per day or less will proceed to the randomized crossover dietary intervention.
Participants in the crossover intervention will complete two 2-week dietary intervention periods separated by a 2-week washout period. They will be randomized to consume either intermediate wheatgrass-based products first or whole wheat-based products first. During each intervention period, participants will consume two slices of bread and 1/2 cup of puffed cereal per day. No additional dietary instruction will be provided.
Gut health will be assessed using stool samples and the Gut Microbiome Wellness Index. Gastrointestinal symptoms and bowel movement patterns will be assessed using a modified Gastrointestinal Symptom Rating Scale questionnaire. Additional dietary intake information will be collected using diet recalls and a food logging smartphone application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than 18 years of age
- •Regular access to a smartphone
- •Willingness to consume bread products daily in accordance with study procedures
排除标准
- •Antibiotic use within 3 months
- •Underlying chronic gastrointestinal disease, including irritable bowel syndrome, inflammatory bowel disease, and celiac disease
- •History of malabsorptive bariatric surgery or colectomy
- •Use of medications known to influence the gut microbiome
- •In the opinion of the investigator, unable to complete study procedures
- •Pregnant women
- •Prisoners
- •Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- •Non-English speakers
- •Individuals unable to read
研究组 & 干预措施
Intermediate Wheatgrass Products First, Then Whole Wheat Products
Participants randomized to this sequence will consume intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then whole wheat-based bread and puffed cereal daily for 2 weeks.
干预措施: Intermediate Wheatgrass-Based Products (Dietary Supplement)
Intermediate Wheatgrass Products First, Then Whole Wheat Products
Participants randomized to this sequence will consume intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then whole wheat-based bread and puffed cereal daily for 2 weeks.
干预措施: Whole Wheat-Based Products (Dietary Supplement)
Whole Wheat Products First, Then Intermediate Wheatgrass Products
Participants randomized to this sequence will consume whole wheat-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks.
干预措施: Intermediate Wheatgrass-Based Products (Dietary Supplement)
Whole Wheat Products First, Then Intermediate Wheatgrass Products
Participants randomized to this sequence will consume whole wheat-based bread and puffed cereal daily for 2 weeks, followed by a 2-week washout period, then intermediate wheatgrass-based bread and puffed cereal daily for 2 weeks.
干预措施: Whole Wheat-Based Products (Dietary Supplement)
结局指标
主要结局
Change in Gut Microbiome Wellness Index
时间窗: Baseline through 6 weeks
Change in Gut Microbiome Wellness Index will be assessed using stool sample-based microbiome analysis and compared after daily consumption of intermediate wheatgrass-based products versus whole wheat-based products.
次要结局
- Change in Gastrointestinal Symptom Scores(Baseline through 6 weeks)