The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123 overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3 (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
Hradec Králové
Hradec, Czechia
Charles University
Prague, Czechia
University of Cophenhagen
Copenhagen, Denmark
Federico University Hospital
Naples, Italy
Policlinico Umberto I
Change in Body Weight
Change from baseline in kilograms and percent (%) weight
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Body weight responders
Change from baseline in body weight of at least 5%
Time frame: 12 weeks
Change in waist circumference
Change from baseline in waist circumference (centimeters)
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in fat mass
Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
Time frame: Measured at weeks 0 and 13
Change in bone-free fat mass
Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)
Time frame: Measured at weeks 0 and 13
Change in appetite (hunger, satiety, and fullness)
Assessed by self-administered Visual Analog Scale (VAS)
Time frame: Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Change in food intake
Assessed by 24 hr dietary recall
Time frame: Measured at weeks 0 and 12
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Rome, Italy