Dyslipidemia, Obesity &Amp; Overweight
Conditions
Keywords
High-protein Compound Beverages, Nutrilite Protein MetX pro
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo Product
A total of 4 cans (460 g/can) of placebo products are distributed to each participant. Participants need to take 16g each time, twice a day, for 4 weeks.
DIETARY_SUPPLEMENTNutrilite Protein MetX Pro
A total of 4 cans (460 g/can) of study products (Nutrilite Protein MetX Pro) are distributed to each participant. Participants need to take 16g each time, twice a day, for 4 weeks.
Sponsors
Amway (China) R&D Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 28. 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile index-TC | 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 | 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 | 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; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of AE and SAE | baseline day 0, through day 28 | The number of AE(Adverse Event) and SAE(Serious Adverse Event) associated with study product, reported during the trial period. |
Countries
China
Outcome results
None listed