Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in circulating choline
研究概览
简要总结
The goal of this clinical trial is to find out if dairy is a good source of choline compared to eggs. The main questions it aims to answer are:
- How the body uses choline; and,
- What effect WPPC has on choline metabolism.
Researchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.
Participants will drink a chocolate-flavored smoothie mixed with either WPPC or whole egg powder.
详细描述
This study is intended to evaluate the bioavailability and metabolism of choline in WPPC compared to the most commonly -used food for bioavailable choline, whole egg. The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women.
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
- Single (Participant)
入排标准
- 年龄范围
- 51 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages between 51 and 70
- •Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and
- •Menopause is when a woman's menstrual periods stop permanently (at least 12 months))
- •Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
- •Had stable body weight (± 5%) for the past 6 months
- •Free from cancer
- •Did not have weight loss surgery, colon surgery
- •Do not have chronic kidney diseases
- •Do not have malabsorption towards fat and dairy products
- •Willing to complete health surveys
- •Willing to complete two 4-day food diaries
- •Willing to consume the intervention smoothies
- •Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention
排除标准
- •On weight loss/weight gain diets
- •Diagnosed with fat malabsorption
- •Undergoing weight loss surgery
- •Diagnosed with chronic kidney diseases
- •Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, chocolate, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds, banana, strawberry, raspberry, blackberry, blueberry.)
- •Regularly using antibiotics or probiotics or prebiotics
- •Regularly using weight-loss drugs (GLP-1, Orlistat, Cetilistat, etc.)
- •Regularly using laxatives
- •Unable to avoid strenuous exercise during the study (>4 h vigorous exercise per day)
研究组 & 干预措施
Pasteurized whole egg powder
Participants will drink a chocolate-flavored smoothie with egg powder added
干预措施: Whole egg powder (Dietary Supplement)
Whey Protein Phospholipid Concentrate (WPPC)
Participants will drink a chocolate-flavored smoothie with WPPC added
干预措施: WPPC (Dietary Supplement)
结局指标
主要结局
Change in circulating choline
时间窗: Baseline to 10 days
Circulating choline will be measured by UHPLC-HRMS/MS
次要结局
- Change in co-factors in circulating choline(Baseline to 10 days)
- Change in high-sensitivity C-reactive protein (hs-CRP)(Baseline to 10 days)
- Change in circulating choline metabolites(Baseline to 10 days)
- Change in 8-hydroxydeoxyguanosine(Baseline to 10 days)
- Change in aspartate transaminase(Baseline to 10 days)
- Change in alanine transaminase (ALT)(Baseline to 10 days)
- Change in creatinine(Baseline to 10 days)