A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study

Abstract

Objective: A proprietary natural fiber complex (Litramine IQP G-002AS) derived from Opuntia ficus-indica, and standardized on lipophilic activity, was previously shown in preclinical and human studies to reduce dietary fat absorption through gastrointestinal (GI) fat binding. Here, we investigated the efficacy and safety of IQP G-002AS in body weight reduction.

Design and methods: One hundred twenty-five overweight and obese adults participated in the study. Subjects were advised on physical activity, and received nutritional counseling, including hypocaloric diet plans (30% energy from fat and 500 kcal deficit/day). After a 2-week placebo run-in phase, subjects were randomized to receive either 3 g/day of IQP G-002AS (IQ) or a placebo. The primary endpoint was change in body weight from baseline; secondary endpoints included additional obesity measures and safety parameters.

Results: One hundred twenty-three subjects completed the 12-week treatment phase (intention-to-treat (ITT) population: 30 male and 93 female; mean BMI: 29.6 ± 2.8 kg/m(2) and age: 45.4 ± 11.3 years). The mean body weight change from baseline was 3.8 ± 1.8 kg in IQ vs. 1.4 ± 2.6 kg in placebo (P < 0.001). More IQ subjects lost at least 5% of their initial body weight compared to placebo (P = 0.027). Compared with placebo, IQ also showed significantly greater reduction in BMI, body fat composition, and waist circumference. IQ was well tolerated with no adverse reactions reported.

Conclusions: These results suggest that the natural fiber complex Litramine IQP G-002AS is effective in promoting weight loss.

Trial registration: ClinicalTrials.gov NCT01233349.

FIGURE 1

Study design and disposition of subjects. ITT, intention-to-treat.

FIGURE 2

Body weight reduction over time. All data are presented as mean ± s.e.m. Asterisks denote significant difference (P < 0.001) of body weight between IQP G-002AS and placebo (derived from ANOVA).

FIGURE 3

Percentage of subjects who lost at least 3, 5, and 10% of initial body weight. Asterisks denote significant difference between IQP G-002AS and placebo (derived from χ²).