Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia
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
1 other identifier
interventional
66
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
2 active sites
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2025
CompletedFirst Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedJuly 30, 2025
July 1, 2025
3 months
July 22, 2025
July 28, 2025
Conditions
Keywords
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 COMPARATORNutrilite 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 COMPARATORPlacebo product , 460g per pack. Ingredient: Maltodextrin.
Interventions
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.
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 Criteria
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
Jinhua Wenrong Hospital
Jinhua, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Cao
Jinhua Wenrong Hospital
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