NCT07094022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 22, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

High-protein Compound BeveragesNutrilite Protein MetX pro

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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;

    baseline day 0, day 28

Secondary Outcomes (1)

  • Number of AE and SAE

    baseline day 0, through day 28

Study Arms (2)

Nutrilite Protein MetX Pro

ACTIVE COMPARATOR

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.

Dietary Supplement: Nutrilite Protein MetX Pro

Placebo Product

PLACEBO COMPARATOR

Placebo product , 460g per pack. Ingredient: Maltodextrin.

Dietary Supplement: Placebo Product

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.

Nutrilite Protein MetX Pro
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.

Placebo Product

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Raison Biotech Group Shanghai Lab

Shanghai, Shanghai Municipality, China

Location

Jinhua Wenrong Hospital

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

DyslipidemiasObesityOverweight

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan Cao

    Jinhua Wenrong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 30, 2025

Study Start

March 16, 2025

Primary Completion

June 3, 2025

Study Completion

June 3, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations