A Randomized, Double-blind, Placebo-controlled, Single Center Study to Evaluate of the Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Lipid profile index-TC
研究概览
简要总结
The goal of this randomized, double-blind, placebo-controlled, single center study is to evaluate the impact of Nutrilite Protein MetX Pro (the study product, a high-protein compound beverages supplemented with multiple plant proteins and apple extracts) on lipid profiles in the blood test in overweight individuals with dyslipidemia. The main question it aims to answer is:
- Does the intake of the study product improve the blood lipid profiles (TC,TG, LDL-C ) in terms of of overweight individuals with dyslipidemia?
Researchers will compare the product group to a placebo group to see whether the blood lipid profile is significantly better improved for participants in the product group.
Participants will:
- take randomly assigned products 16g/each time, twice a day for 4 weeks
- make four times site visits, once a week. Blood samples are collected for each visit, and Feces are collected for the first and last site visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Age: 18-65 years old
- •Overweight or obese participants, 40 with a BMI of 24-28 kg/m², and 40 participants with a BMI greater than
- •The percentage of male participants is ≥40%. And the lipid profile with the following characteristics:
- •TC (Total Cholesterol): 5.18-6.21 mmol/L;
- •TG(Triglyceride): 1.70-2.25 mmol/L;
- •LDL-C(Low-Density Lipoprotein Cholesterol): ≥ 3.4 mmol/L;
- •Agree to sign the informed consent form.
排除标准
- •Pregnant or lactating women, those with allergic constitutions, or those allergic to this test sample.
- •Patients with severe diseases of the heart, liver, kidneys and hematopoietic system, as well as those with mental illness.
- •Those who have taken lipid-lowering drugs or the like in the past two weeks, which has affected their judgment of the results.
- •Patients with hyperlipidemia.
- •The researcher determined that the participant was not suitable for this trial.
结局指标
主要结局
Lipid profile index-TC
时间窗: baseline day 0, day 28
TC (Total Cholesterol) concentration level in the blood sample test: normal range 3-5.2 mmol/L; higher than 5.2 mmol/L is abnormal.
Lipid profile index-TG
时间窗: baseline day 0, day 28
TG (Triglyceride) concentration level in the blood sample test : normal range 0\~1.7 mmol/L, higher than 1.7mmol/L is abnormal
Lipid profile index-LDL-C
时间窗: baseline day 0, day 28
LDL-C(Low-Density Lipoprotein Cholesterol) concentration level in the blood sample test: normal range 0-3.1mmol/L, higher than 3.1 mmol/L is abnomal;
次要结局
- Number of AE and SAE(baseline day 0, through day 28)