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Effect of Green Banana Biomass on Overweight men and women’s health

Effect of Green Banana Biomass consumption associated with Energy Restricted Diet on gut and related variables in individuals with Excess Weight and Body Fat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-379g2cz
Enrollment
Unknown
Registered
2024-03-30
Start date
2023-10-16
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

Obesity

Interventions

This is a 12-week, two-arm, double-blind, randomized controlled clinical study. Biomass Experimental Group: 42 overweight or obese men and women will receive a breakfast flavored milk drink containing
B01.875.800.575.912.250.618.937.555.500
D05.750.078.562.855.875

Sponsors

Universidade Federal de Viçosa
Lead Sponsor
Universidade Federal de Viçosa
Collaborator

Eligibility

Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Men and women; between 20 and 40 years old; body mass index between 25 and 34.9 kilograms per meter squared; body fat percentage above 30; food inhibition/disinhibition level less than or equal to 14; weight loss of less than 3 kilograms in the last 12 weeks; level of physical activity stable between irregularly active and active; who consume breakfast regularly

Exclusion criteria

Exclusion criteria: Smokers; pregnant/breastfeeding women; women who have menstrual irregularities in the last three months; elite athletes; consumption of probiotics, prebiotics or synbiotics more than 2 times/week in the month before the start of the study; changes in the level of physical activity and body weight greater than 3 kilos in the last three months; vegetarians; regular consumption of alcohol; use of supplements or medications; presence of allergy or food intolerance or aversion to the tested ingredients; gastrointestinal diseases; chronic diseases

Design outcomes

Primary

MeasureTime frame
It is expected to verify a 7 percent reduction in the participants' body weight, assessed using an anthropometric scale, after consuming green banana biomass for 12 weeks;It is expected to see an improvement in intestinal health, verified by genetic sequencing; reduction in fecal short-chain fatty acids concentration, verified by high-performance liquid chromatography; reduction in intestinal permeability, verified by enzyme-linked immunosorbent assays, after consuming green banana biomass for 12 weeks

Secondary

MeasureTime frame
It is expected a 30 percent reduction in serum concentrations of advanced glycation end products, verified by commercial immunoenzymatic assay kits, after consumption of green banana biomass for 12 weeks;It is expected a 15 percent improvement in plasma concentrations of inflammatory cytokines, assessed by flow cytometry, after consumption of green banana biomass for 12 weeks

Countries

Brazil

Contacts

Public ContactNatália Bomfim

Universidade Federal de Viçosa

natalia.bomfim@ufv.br+55(31)3612-5227

Outcome results

None listed

Source: REBEC (via WHO ICTRP)