METHODS: A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual's energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study.
RESULTS: After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p < 0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p < 0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported.
CONCLUSIONS: These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.
METHODS: A group of healthcare university students completed the RSES across three waves: baseline, 1-week follow-up, and 15-week follow-up. A total of 481 valid responses were collected through the three-wave data collection process. Exploratory factor analysis (EFA) was performed on the baseline data to explore the potential factorial structure, while confirmatory factor analysis (CFA) was performed on the follow-up data to determine the best-fit model. Additionally, the cross-sectional and longitudinal measurement invariances were tested to assess the measurement properties of the RSES for different groups, such as gender and age, as well as across different time points. Convergent validity was assessed against the Self-Rated Health Questionnaire (SRHQ) using Spearman's correlation. Internal consistency was examined using Cronbach's alpha and McDonald's omega coefficients, while test-retest reliability was assessed using intraclass correlation coefficient.
RESULTS: The results of EFA revealed that Items 5, 8, and 9 had inadequate or cross-factor loadings, leading to their removal from further analysis. Analysis of the remaining seven items using EFA suggested a two-factor solution. A comparison of several potential models for the 10-item and 7-item RSES using CFA showed a preference for the 7-item form (RSES-7) with two factors. Furthermore, the RSES-7 exhibited strict invariance across different groups and time points, indicating its stability and consistency. The RSES-7 also demonstrated adequate convergent validity, internal consistency, and test-retest reliability, which further supported its robustness as a measure of self-esteem.
CONCLUSIONS: The findings suggest that the RSES-7 is a psychometrically sound and brief self-report scale for measuring self-esteem in the Chinese context. More studies are warranted to further verify its usability.