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

Not Applicable

Completed

• Conditions: Dyslipidemia; Obesity &Amp; Overweight

• Registration Number: NCT07094022
• Lead Sponsor: Amway (China) R&D Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-16
• Primary Completion: 2025-06-03
• Study Completion: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Raison Biotech Group Shanghai Lab; 🇨🇳 Shanghai, Shanghai, China

Jinhua Wenrong Hospital; 🇨🇳 Jinhua, Zhejiang, China