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

Amway

Status: Completed

Conditions: Obesity &Amp; Overweight; Dyslipidemia

Treatments: Dietary Supplement: Placebo Product; Dietary Supplement: Nutrilite Protein MetX Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT07094022

23-RD-08-AY-001

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Nutrilite Protein MetX Pro

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutrilite Protein MetX Pro

Placebo Product

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Product