NCT07799207招募中不适用
Randomized, Double-Blind, Controlled Study on the Effects of Continuous Yogurt Intake on Immunomodulatory Function and Subjective Health Status in Healthy U.S. Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Salivary IgA flow rate
研究概览
简要总结
This study evaluates the effects of daily consumption of a yogurt on immune function and subjective health status in healthy adults in the United States. Participants are randomly assigned to receive either the active yogurt or a placebo once daily for 8 weeks. The study assesses immune function using salivary immunoglobulin A and other immune-related biomarkers. The study also evaluates cold-like symptoms, quality of life, gastrointestinal symptoms, stress, and sleep-related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent.
- •Be between 18-65 years, inclusive.
- •Be in general good health, as determined by the in investigator.
- •Willing to consume study product daily for the duration of the study.
- •Has a body mass index (BMI) ≤39.9 kg/m2
- •Willing to refrain from consuming alcohol for the 24 hours prior to each study visit.
- •Willing to maintain current lifestyle habits, including dietary and caffeine and alcohol intake, for the duration of the study.
排除标准
- •Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- •Participants currently of biological childbearing potential, but not using a continuous effective method of contraception.
- •Has a history of drug and/or alcohol abuse at the time of enrolment.
- •Drinks more than nationally recommended units of alcohol per day/week.
- •Has milk allergy or other food allergies or other issues with foods that would preclude intake of the SP.
- •Has an excessive smoking habit.
- •Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and laboratory test results.
- •Dental or intraoral treatment.
- •Visited a hospital or clinic for allergic rhinitis (pollinosis) within the past year or those who plan to take prescription drugs to treat or prevent allergic rhinitis during the study period.
- •Current or recent (in the past 4 weeks) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
- •Current or recent (in the past 4-weeks) use of prohibited nutritional or non-nutritional dietary supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
- •Current or recent (in the past 2 weeks) use of yogurt (other than the study product)
- •Participants who have donated blood in the previous 8-weeks.
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
研究组 & 干预措施
Placebo study product
Placebo Comparator
Participants receive 120 g of the acidified lactic beverage once daily for 8 weeks.
干预措施: Acidified lactic beverage (Dietary Supplement)
Active study product
Experimental
Participants receive 120 g of the yogurt drink once daily for 8 weeks.
干预措施: Yogurt drink (Dietary Supplement)
结局指标
主要结局
Salivary IgA flow rate
时间窗: Baseline (Week 0) and Endpoint (Week 8)
Saliva is collected by allowing naturally secreted saliva to passively drool into a sterile collection tube or vial without chewing or making oral movements. The time required to collect the specified volume of saliva is recorded. The salivary IgA flow rate is calculated by multiplying the salivary IgA level by the slivary flow rate.
次要结局
- Cold-like symptoms and absenteeism(from baseline to Week 8)
- Salivary IgA flow rate (baseline to 4 weeks)(Baseline (Week 0), Midpoint (Week 4))
- Salivary IgA level(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Expression intensity and frequency of immune cell activation markers(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Concentration of Inflammatory Cytokines in Blood(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Gastrointestinal symptoms (GSRS - total score)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Quality of Life (SF-36 RAND - General Health and Energy/Fatigue Domain Scores)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- DASS-21- Stress Score(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Sleep Disturbance 8A (SD 8A)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Sleep related impairment 8A (SRI 8A)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Effect Of Whole or Skimmed Milk Greek Yogurt on Integrated Muscle Protein Synthesis, Glucose Homeostasis, and Cognition in Post-Menopausal WomenObesity & OverweightWomenMenopauseNCT07705724University of Arkansas40
招募中
不适用
CLL-IMPACT: A Clinical Nutrition Trial Investigating Immune and Metabolic Changes in Early-Stage CLLNCT07487428Technical University of Munich50
尚未招募
2 期
A study of TolerGen™ capsules for immune health in adultsCTRI/2026/01/101467PhytoVeda Pvt. Ltd.60
尚未招募
2 期
To study the effect of beheda churna vati in cough.CTRI/2025/08/092836Maharashtra University of Health Sciences,Nashik under the scheme of STRG72
尚未招募
1 期
Encapsulated Probiotics & Gut MicrobiotaNCT07439978University College Dublin50