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NCT Number: NCT07094022

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raison Biotech Group Shanghai Lab, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrilite Protein MetX Pro

Dietary 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 product

Dietary 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.

Primary outcomes

  1. Lipid profile index-TC

    Time frame: 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.

  2. Lipid profile index-TG

    Time frame: 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

  3. Lipid profile index-LDL-C

    Time frame: 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 outcomes

  1. Number of AE and SAE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amway (China) R&D Center

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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