Effect of Co-consuming Different Dietary Protein Sources With Salad on the Bioavailability of Carotenoids
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Plasma carotenoids
研究概览
简要总结
The goal of this clinical trial is to learn if different protein types will affect carotenoid responses in humans when co-consumed with salad. The main questions it aims to answer are:
- What are the effect of dietary protein co-consumption with salad on postprandial carotenoid levels in Singapore adults?
- Do different whole-food protein sources enhance the bioavailability of carotenoids in Singapore adults?
Participants will:
Consume salad with a form of protein (chicken, tuna, egg, soybean) Have their postprandial plasma carotenoid and triglyceride outcomes evaluated
详细描述
This study will be a single-blind, randomized, crossover acute trial, and all participants will complete an approximately 3-month study period. A total of 19 participants will be recruited and go through all 5 arms (4 intervention and 1 control), with the order randomized. The study will comprise 1 screening visit and 5 test visits, with another 5 compliance visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-literate and able to give informed consent
- •Singaporean Adults aged 21 to 45 (inclusive)
- •Body mass index of 18.5 to 23.0 kg/m2 (inclusive)
- •At least 50 kg
- •Healthy (based on screening results)
排除标准
- •Currently participating in another clinical study that involves altering regular diet and/or involves consuming a dietary supplement or investigated food product as an intervention
- •High blood pressure (≥ 140/90 mmHg)
- •Underlying health conditions that may affect metabolic functions
- •Consuming carotenoid supplements regularly (i.e., more than three times a week) for the past 3 months, and not willing to discontinue consumption 3 months before and during the study duration
- •Weight change > 3 kg in the past 3 months
- •Exercising vigorously over the past 3 months (i.e., engaging in high-intensity exercises for more than 3 hours a week, where high-intensity exercises leave one out of breath and unable to talk or sing during the workout)
- •Current smokers or have quit smoking for less than 5 years
- •Drinking > 2 alcoholic drinks per day (i.e., one drink is defined as either 150 ml of wine, 340 ml of beer/cider or 45 ml of distilled spirit)
- •If drinking ≤ 2 alcoholic drinks per day, not willing to stop consumption of alcoholic beverages two days before and on the day of the test visits
- •Not willing to stop consumption of caffeinated beverages 10 to 12 hours before and on the day of the test visits
- •Currently on a specialised diet (e.g., vegetarian, vegan, weight loss diet)
- •Had serious food allergies in the past, or having intolerance, sensitivities or allergies to any of the following: soy/soy-derived products, eggs, fish and crustaceans, starch/starch-derived products (e.g., rice, corn, wheat, potato), gluten
- •Disease or impairment of the liver
- •Currently diagnosed with diabetes, gastrointestinal issues (e.g., lactose intolerance, irritable bowel syndrome), gout and/or G6PD deficiency
- •Taking antibiotics 2 weeks prior to study participation
- •Taking anti-hypertensive or cholesterol-lowering drugs for less than 3 years unless medically declared by an official doctor to be in stable condition
- •Poor peripheral venous access based on past experiences with blood drawing
- •Individuals with pacemaker or related electrical medical devices
- •Pregnant, lactating, or planning pregnancy in the next 6 months
- •Have donated blood (whole blood or apheresis) or participated in any other clinical study or trial requiring blood draws within the last 3 months
- •Clinical anemia (hemoglobin <12.0 g/dL in women and <13.0 g/dL in men)
研究组 & 干预措施
Salad + Chicken
Salad with chicken
干预措施: Salad + Chicken (Other)
Salad + Egg
Salad with egg
干预措施: Salad + Egg (Other)
Salad + Soybean
Salad with soybeans
干预措施: Salad + Soybean (Other)
Salad + Tuna
Salad with tuna
干预措施: Salad + Tuna (Other)
Salad only
Salad only (no protein)
干预措施: Salad only (Other)
结局指标
主要结局
Plasma carotenoids
时间窗: From start of salad consumption to the end of acute period (8 hours)
Postprandial plasma carotenoids response
Triglycerides
时间窗: From start of salad consumption to the end of acute period (8 hours)
Postprandial triglyceride response
Concentration of plasma carotenoids
时间窗: From start of salad consumption to the end of acute period (8 hours)
Concentration of plasma carotenoids hourly
Concentration of blood triglycerides
时间窗: From start of salad consumption to the end of acute period (8 hours)
Postprandial triglyceride response
次要结局
未报告次要终点
研究者
Jung Eun Kim
Associate Professor
National University of Singapore