NCT06645171尚未招募不适用
Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition
Nutricia Research0 个研究点目标入组 62 人开始时间: 2024年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Changes in gut microbiota bifidobacterial levels
研究概览
简要总结
This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age or older
- •Identified as at medium or high risk of malnutrition based on:
- •a) MNA-SF score between 0 - 11 and / or b) are prescribed with ONS
- •In need of 2 servings of oral nutritional support/day (300 kcal; 12 gr protein per serving).
- •a) Not being prescribed with ONS or b) being prescribed with non-fibre containing ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study.
- •Willing to maintain dietary habits for the duration of the study. Written informed consent from subject (or impartial witness after verbal consent of subject when subject is physically unable to sign and where allowed by local regulations).
排除标准
- •Requirement for a fibre-free diet.
- •Have used nutritional supplements with fibre/prebiotics and/or probiotics content at any point during 3 weeks prior to start study (Visit 1) and / or will not refrain from using these kinds of products during the study period.
- •Admitted to an intensive care unit.
- •Hemodynamically unstable.
- •Known allergy to cow's milk protein.
- •Known galactosaemia.
- •Known hepatic encephalopathy.
- •Known Irritable Bowel Syndrome.
- •Known severe lactose intolerance without using lactase.
- •Known history of GI surgery.
- •Known history of intestinal polyp removal within 3 months prior to the study.
- •Known history of Immunotherapy.
- •Known history of GI cancer.
- •Active cancer treatment or within 12 months prior the study
- •Diagnose of Celiac Disease.
- •Received antibiotics within 4 weeks prior to study.
- •Patients following a vegan or vegetarian diet.
- •Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn's disease) or SCCAI >5 (ulcerative colitis).
- •Stricturing Crohn's disease.
- •Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease.
- •Planned hospital admission during the study period in case not hospitalised at screening
- •Participation in any other studies involving investigational or marketed products concomitantly or within 6 weeks prior to baseline.
- •Severe disease with life expectancy less than a year.
结局指标
主要结局
Changes in gut microbiota bifidobacterial levels
时间窗: 4 weeks
次要结局
- Changes in gut microbiota composition(4 weeks)
- Fecal pH(4 weeks)
- Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS)(4 weeks)
- Total short-chain fatty acids (SCFA)(4 weeks)
研究者
相似试验
招募中
2 期
The effect of oral nutrition supplement (ONS) on autologous hematopoietic stem cell transplantatioMultiple myelomaCondition 1: Lymphoma. Condition 2: multiple myeloma.Non-Hodgkin lymphoma, unspecifiedC85.9C90.0IRCT20220208053971N2Tehran University of Medical Sciences38
尚未招募
不适用
Efficacy of increased dietary fibre intake on body composition, weight loss and healthOverweight & ObesityDiet and Nutrition - ObesityACTRN12620000587909Queensland University of Technology150
招募中
不适用
The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancerPatients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapyJPRN-UMIN000006274Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology50
已完成
不适用
Effect of Oral Nutritional Supplementation Combined With Impedance VectorsChronic Kidney Disease Requiring Chronic DialysisOverhydrationUndernutritionNCT05288101Universidad Autonoma de Queretaro39
已完成
3 期
A study of an oral nutrition supplement (ONS) in childreCTRI/2014/07/004717Abbott Nutrition International India256