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A double blind placebo controlled clinical trial evaluating the effects of LPT3‐04 on body weight & composition in overweight & mildly obese healthy adults
Author(s) -
Kalman Douglas,
Feldman Samantha
Publication year - 2012
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.26.1_supplement.lb399
Subject(s) - overweight , placebo , medicine , weight loss , body weight , obesity , zoology , endocrinology , composition (language) , differential effects , biology , linguistics , philosophy , alternative medicine , pathology
In a 12 wk RDBPCT, 32 healthy overweight/obese adults (43.5±11.6y.o; 29.33±2.52mg/m2) were allotted to either the LPT3‐04 or Placebo (n=16 per group). Over the 12‐weeks of the study, tests were standardized at baseline & weeks 4, 8 & 12. The tests of interest included body weight, composition & safety markers. All subjects were instructed on caloric intake (RMRx1.3 AF ‐ 500) coupled with a 5d/wk exercise program of moderate intensity for 30 min/session & compliance assessed via dichotomous questionnaires. Body weight was measured in minimal essential clothing on a calibrated digital scale, while body composition was measured by DEXA. Safety markers included CMP, CBC w/differential, vitals, AE's & subjective remarks over the 12/wk period. Weight loss was significantly different between the groups, favoring the LPT group (LPT −3.01±2.32kg vs. Pla −1.65±2.55kg; p=0.037). Change in % body fat did not differ between the groups, both groups lost significant amount of fat mass (LPT −4.06±4.51kg p=0.005 & Pla −3.61±3.97 kg p=0.013). There was a borderline significant difference for change in fat free mass (LPT −2.29±3.12kg vs. Pla 0.192.77kg; p=0.051). There were no SAE's or difference in AE's between the groups, nor any clinically significant changes in lab values observed. The results of this study support a weight loss effect for LPT, the active group lost significantly more weight than the placebo.