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A Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Effect of Sinetrol on Body Composition &Metabolic Health in Peri-menopausal/Early Menopausal Women

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Effect of Sinetrol on Body Composition &Metabolic Health in Peri-menopausal/Early Menopausal Women (MENOFIT)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07782853
Acronym
MENOFIT
Enrollment
200
Registered
2026-08-24
Start date
2026-09-01
Completion date
2028-12-01
Last updated
2026-08-24

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

Conditions

to Assess Changes in Body Composition After Dietary Supplementation With Sinetrol

Brief summary

The menopausal transition is associated with significant hormonal and metabolic changes, primarily driven by a decline in estrogen levels. These changes contribute to alterations in body composition, including an increase in total body fat, preferential accumulation of central and visceral adipose tissue, and a reduction in lean body mass. Such redistribution of adiposity is a defining feature of peri- and early postmenopausal stages and is closely linked to increased cardiometabolic risk. Visceral adipose tissue is metabolically active and contributes to the development of insulin resistance, dyslipidemia, and chronic low-grade inflammation through the secretion of pro-inflammatory cytokines and adipokines.These metabolic alterations may adversely impact overall health, physical function, and quality of life in peri- and postmenopausal women. In addition, menopause-associated changes in energy expenditure and appetite regulation may further predispose individuals to weight gain and fat accumulation. Conventional management strategies for weight gain during menopause include lifestyle interventions such as dietary modification and physical activity; however, long-term adherence to these approaches is often limited. Pharmacological options may also be associated with safety concerns or may not directly address body composition changes. Therefore, there is increasing interest in nutraceutical approaches that may safely support metabolic health and body composition in this population.6 Sinetrol XPur C is a standardized polyphenolic extract derived from citrus fruits, including red orange, grapefruit, and sweet orange, enriched with flavonoids such as naringin and hesperidin. These bioactive compounds have been shown to influence lipid metabolism and adipocyte function. Clinical studies have demonstrated the potential of Sinetrol XPur C in supporting body composition management. The available clinical evidence suggests that Sinetrol XPur C may support body composition and metabolic health through mechanisms involving enhanced lipolysis, improved energy metabolism, and modulation of adipose tissue function. Given the physiological changes associated with menopause and the need for safe and effective interventions, Sinetrol XPur C may represent a promising nutritional approach for improving body composition and related metabolic parameters in peri- and early postmenopausal women. The study objective is to assess the effect of Sinetrol XPur C on Body composition (Total fat mass and fat free mass) using Dual-Energy- X-ray Absorptiometry (DEXA) when compared to baseline and placebo.

Interventions

DIETARY_SUPPLEMENTdietary supplementation

dietary supplementation

Sponsors

DR Healthcare - biotexia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 62 Years
Healthy volunteers
Yes

Inclusion criteria

* perimenopausal or early menopausal women

Exclusion criteria

* women under HRT treatment

Design outcomes

Primary

MeasureTime frameDescription
Body composition (Total fat mass and fat free mass) when compared to baseline and placebo.180 daysTo assess the effect of Sinetrol XPur C on Body composition (Total fat mass and fat free mass) using Dual-Energy- X-ray Absorptiometry (DEXA) when compared to baseline and placebo.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026