Postmenopause
Conditions
Interventions
This is a one-arm clinical trial study. 14 postmenopause women will consume 2g of D-limonene per day for 3 weeks. Before and after the supplementation, a dietary challenge will be performed, evaluatin
SP6.051.227
Sponsors
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women in post menopause period; Body Mass Index between 18.5 and 34.9 kilograms per square meter; age between 50 and 65 years
Exclusion criteria
Exclusion criteria: Bariatric surgery; gastrectomy; surgeries that alter the size of the stomach or intestine; inflammatory bowel diseases; celiac disease; gastric ulcers; liver diseases; cholecystectomy; diabetes; casein allergy; lactose intolerance; alcoholism; use of antimicrobial therapy at the time of the study and up to 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1= D-limonene supplementation improves lipid metabolism, blood glucose and inflammation in postmenopause women. In relation to metabolomics, is expect to analyse D-limonene metabolytes in urine samples and if there is difference between the volunteers;Outcomes found 1= Molecules were identified by high-resolution mass spectrometry and in urine samples, the following D-limonene metabolites were found: perillic acid-8,9-diol glucuronide, dihydroxy-p-mentha-8-en -7-oic acid glucuronide, hydroxy-p-menth-8-en-7-oic acid glucuronide, uroterpenol glucuronide (2 isomers). Nine participants completed the experimental protocol. In the baseline assessment, before and after 3 weeks), supplementation with D-limonene for 3 weeks had no effect on anthropometric parameters (weight, body mass index, percentage of body and visceral fat), as well as on blood glucose and profile lipid levels (total cholesterol, LDL-c, HDL-c, VLDL, triglycerides, and non-HDL cholesterol) measured by commercial kits in an automated biochemical analyzer. For insulin and inflammatory markers (TNF-alpha, IL-6, and MCP-1), measured by the Multiplex technique, and for HOMA-IR, no significant difference was observed either. The dosage of non-esterified fatty acids was evaluated by a commercial kit in a microplate reader, and a significant reduction was observed after 3 weeks. During the dietary challenge to assess postprandial metabolism (after ingestion of 1 capsule of D-limonene) at baseline and after 3 weeks, it was observed that the intervention had no effect on glycemic parameters, lipid profile, fatty acids non-esterified, and inflammatory profile | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactJarlei Fiamoncini
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Outcome results
None listed