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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Product | Placebo Comparator | Placebo product , 460g per pack. Ingredient: Maltodextrin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline day 0, through day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Cao | Jinhua Wenrong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raison Biotech Group Shanghai Lab | Shanghai | Shanghai Municipality | China | |||
| Jinhua Wenrong Hospital |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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| 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. |
|
| Jinhua |
| Zhejiang |
| China |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |