Effects of Supplementation of a Component Present in Apples in Menopausal Women with Metabolic Syndrome

Effects of Ursolic Acid Supplementation Associated with a Physical Activity and Nutritional Program in Women with Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-276rrt

Enrollment

Unknown

Registered

2020-05-18

Start date

2019-11-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Interventions

Experimental group: 14 post-menopausal women with metabolic syndrome and participate in a program of physical activity associated with supplementation of ursolic acid, lasting 8 weeks. Control group:

Dietary supplement

Other

G07.203.300.456

G11.427.410.698.277

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: be female; history of spontaneous amenorrhea for a period greater than or equal to 12 months; age between 45 and 70 years; having waist circumference greater than 80 cm associated with two more parameters; fasting blood glucose greater than 100 mg/dL; triglycerides greater than 150 mg/dL, HDL-cholesterol greater than 50 mg/dL; blood pressure greater than 130/85 mmHg or use of antihypertensive drugs.

Exclusion criteria

Exclusion criteria: pregnant or breastfeeding women; who have musculoskeletal disorders that compromise body movement; or some serious heart disease; history of drug and alcohol abuse.

Design outcomes

Primary

Measure	Time frame
Evaluate changes in waist circumference using an anthropometric tape, based on the observation of a variation of at least 5% in the pre and post-intervention measurements	—

Secondary

Measure	Time frame
To evaluate changes in fasting serum glucose levels using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in serum fasting triglyceride concentrations using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in fasting serum cholesterol-HDL levels using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in blood pressure at rest by a validated oscillometric device, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements;Evaluate aerobic functional capacity by a 6-minute walk test, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;Assess handgrip strength using a manual mechanical dynamometer, based on the observation of a variation of at least 5% in the pre and post-intervention measurements	—

Measure

Time frame

To evaluate changes in fasting serum glucose levels using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in serum fasting triglyceride concentrations using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in fasting serum cholesterol-HDL levels using the enzymatic-colorimetric method, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate changes in blood pressure at rest by a validated oscillometric device, based on the observation of a variation of at least 5% in the pre- and post-intervention measurements;Evaluate aerobic functional capacity by a 6-minute walk test, based on the observation of a variation of at least 5% in the pre and post-intervention measurements;Assess handgrip strength using a manual mechanical dynamometer, based on the observation of a variation of at least 5% in the pre and post-intervention measurements

—

Countries

Brazil

Contacts

Public ContactAlex;Rozangela Crisp;Verlengia

Universidade Metodista de Piracicaba;Universidade Metodista de Piracicaba

alexhcrisp@gmail.com;rozverlengia@gmail.com+55 19 3124-1515;+55 19 3124-1515

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 22, 2026