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

NCT07782853 | Not Yet Recruiting

• 1 other identifier: MENOFIT
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

to Assess Changes in Body Composition After Dietary Supplementation With Sinetrol

Outcome Measures

Primary Outcomes (1)

• Body composition (Total fat mass and fat free mass) when compared to baseline and placebo.

  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.

  180 days

Study Arms (2)

investigational product

ACTIVE COMPARATOR

Sinetrol 630 mg/capsule/day

Dietary Supplement: dietary supplementation

placebo

PLACEBO COMPARATOR

maltodextrin

Dietary Supplement: dietary supplementation

Interventions

dietary supplementation DIETARY_SUPPLEMENT

dietary supplementation

investigational product; placebo

Eligibility Criteria

• Age: 45 Years - 62 Years
• Gender Eligibility Details: perimenopausal and early menopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• perimenopausal or early menopausal women

You may not qualify if:

• women under HRT treatment

Sponsors & Collaborators

• DR Healthcare - biotexia: lead

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share