DyslipidemiaNCT07094022
Improvement and Safety of Nutrilite Protein MetX Pro on Weight Management in Overweight Individuals With Dyslipidemia
A study testing Nutrilite Protein MetX Pro in people with Dyslipidemia and Obesity &Amp; Overweight, run by Amway (China) R&D Center at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia, Obesity &Amp; Overweight
- What is being tested?
- Nutrilite Protein MetX Pro
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2025to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jinhua Wenrong Hospital
Jinhua, Zhejiang
Raison Biotech Group Shanghai Lab
Shanghai, Shanghai Municipality
About this study
Official 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
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?
Read more
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.
- Conditions
- Dyslipidemia, Obesity &Amp; Overweight
- Being tested
- Nutrilite Protein MetX Pro, Placebo Product
- Keywords
- High-protein Compound Beverages, Nutrilite Protein MetX pro
- Medical subject headings
- Dyslipidemias, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Nutrilite Protein MetX Pro |
| Placebo Product | Placebo comparator | Placebo product , 460g per pack. Ingredient: Maltodextrin. Receives: Dietary Supplement: Placebo Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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;
Measured: baseline day 0, day 28
Secondary outcomes (1)
Number of AE and SAE
The number of AE(Adverse Event) and SAE(Serious Adverse Event) associated with study product, reported during the trial period.
Measured: baseline day 0, through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start16 Mar 2025
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amway (China) R&D Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Cao, Principal investigator, Jinhua Wenrong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094022
- Sponsor's protocol ID
- 23-RD-08-AY-001
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07094022
- Acronym / sponsor ID
- 23-RD-08-AY-001
- Conditions
- Dyslipidemia, Obesity &Amp; Overweight
- Keywords
- High-protein Compound Beverages, Nutrilite Protein MetX pro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amway (China) R&D CenterIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrilite Protein MetX Pro | Active comparator | Dietary Supplement: Nutrilite Protein MetX ProNutrilite 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 ProductPlacebo product , 460g per pack. Ingredient: Maltodextrin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrilite Protein MetX ProA 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. | Dietary supplement | Nutrilite Protein MetX Pro |
| Placebo ProductA 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. | Dietary supplement | Placebo Product |
Primary outcome
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.
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
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;
1 secondary outcome
Number of AE and SAE
Time frame: baseline day 0, through day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Cao principal investigator
Jinhua Wenrong Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrilite Protein MetX Pro in people with Dyslipidemia and Obesity &Amp; Overweight, run by Amway (China) R&D Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile index-TC (time frame: baseline day 0, day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.