Abstract
Introduction: The aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals. Methods: In a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (Body Mass Index (BMI) 25 to < 35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual’s daily energy requirements) for 12 weeks. At week 0 (baseline), week 4, 8 and 12 of the intervention periods, the participants’ body weight, BMI, body fat composition and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening. Results: At the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo) respectively experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104. Conclusion: Results demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.
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Key Points
Meta-analysis of 45 randomized placebo-controlled trials showed that consumption of whole flaxseed, possibly due to high fiber content had led to significant reduction in body weight, BMI and waist circumference. Findings from previous research showed the potential of flaxseed mucilage in combating obesity however clinical evidence of flaxseed mucilage, especially at a lower dose compared to the whole flaxseed, has not yet been established. The potential of flaxseed mucilage in weight management is promising and to the best of our knowledge, clinical evidence on weight loss effect of flaxseed mucilage was not available. This study aimed to determine the efficacy and tolerability of IQP-LU-104, a proprietary flaxseed mucilage composition, in reducing body weight among the overweight and moderately obese populations.
In this study, there was a slight but statistically significant reduction in total cholesterol and triglycerides levels. There was no significant reduction in blood glucose and HbA1c levels. It has been reported that viscous fiber has no significant effect on individuals with normal cholesterol level as its cholesterol lowering property was highly influenced by the baseline level. In this study with a duration of 12 weeks, participants in 104HD group and 104LD group had a mean reduction of 4.44 ± 2.48 cm and 3.55 ± 1.75 cm respectively in waist circumference compared to placebo at only 0.94 ± 1.20 cm. IQP-LU-104 was well-tolerable in the 12 weeks trial with no major adverse events reported. These observations were consistent with the wide consumption of flaxseed as functional food and dietary supplement. One of the limitations of the present study is that the trial was only performed for a period of 12 weeks with no further follow-up after the intervention period, whereby weight maintenance effect and feedback from participants after weight loss were not investigated. Thus, the results of the study may need to be investigated in further study. Considering future studies, it would be worthwhile to investigate the efficacy of IQP-LU-104 in long-term weight management or integrating IQP-LU-104 into the diet via newer strategies such as nutritional coaching, practice of mindful eating, lifestyle intervention and personalized diet plans, which have been recommended as effective approaches for sustainable weight loss. In conclusion, this is the first clinical evidence of the effect of flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals. Throughout the 12-week intervention period, compliance with IP intake was very good, as was tolerability since no adverse effects related to the intake of IQP-LU-104 were reported. IQP-LU-104 can be conveniently incorporated into a person’s daily meal as an effective lifestyle approach in combating obesity.