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

NCT07094022 — Not applicable, Completed, 66 participants, Amway (China) R&D Center

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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

Registry	NCT07094022
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	66 (Actual)
Sponsor	Amway (China) R&D Center (Industry)
Conditions	Dyslipidemia, Obesity &Amp; Overweight
Interventions	Nutrilite Protein MetX Pro, Placebo Product (Dietary supplement)
Dates	start 2025-03-16, primary completion 2025-06-03, completion 2025-06-03, first posted 2025-07-30, last updated 2025-07-30
Locations	2 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nutrilite Protein MetX Pro	Active comparator	Dietary Supplement: Nutrilite Protein MetX Pro	Nutrilite protein MetX pro, 460g per pack. Ingredients: Mung bean protein, chickpea protein, isomaltulose, rice (glutinous rice) protein, green apple concentrated juice powder, inulin, xanthan gum, guar gum, silicon dioxide, food flavoring.
Placebo Product	Placebo comparator	Dietary Supplement: Placebo Product	Placebo product , 460g per pack. Ingredient: Maltodextrin.

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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (2)

Facility	City	Country	Status
Raison Biotech Group Shanghai Lab	Shanghai, Shanghai Municipality	China
Jinhua Wenrong Hospital	Jinhua, Zhejiang	China

+Investigators

Dan Cao, Principal investigator, Jinhua Wenrong Hospital