Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia

Amway (China) R&D Center66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemia Obesity &Amp; Overweight

Interventions

Nutrilite Protein MetX ProDIETARY_SUPPLEMENT

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.

Placebo ProductDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Lipid profile index-TC

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.

Time frame: baseline day 0, day 28

Lipid profile index-TG

TG (Triglyceride) concentration level in the blood sample test : normal range 0\~1.7 mmol/L, higher than 1.7mmol/L is abnormal

Time frame: baseline day 0, day 28

Lipid profile index-LDL-C

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;

Time frame: baseline day 0, day 28

Secondary Outcomes

Number of AE and SAE

The number of AE(Adverse Event) and SAE(Serious Adverse Event) associated with study product, reported during the trial period.

Time frame: baseline day 0, through day 28

Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes