Project Progress: Human Intervention Trials

22 Oct 2019

Globally, the incidence of obesity and related metabolic diseases are steeply increasing, and this has major consequences both for individuals as well as the health care system worldwide. This urgently calls for early preventive strategies, but also for treatments targeting the early developing stages of diseases such as metabolic syndrome. The gastrointestinal system and the gut microbiome in particular have been proposed as a key target for such interventions. A dysbiotic, or altered, gut microbiome has been associated with increased metabolic and immune disorders in humans, affecting insulin secretion, fat accumulation, energy homeostasis and plasma cholesterol levels and initially manifests as metabolic syndrome, a health condition that places people at a higher risk of cardiovascular diseases, type 2 diabetes and some cancers. Therefore, the gut microbiome may serve as a potential therapeutic target for metabolic syndrome. However, only a few potential candidates for alleviating metabolic syndrome via gut microbiome manipulation have been tested in humans.

This is about to change with the SIMBA project. As part of Work Package 5, a novel, sustainable, fermented plant-based dietary supplement will be tested on humans. The product, developed by our partner FermBiotics, is a fermented canola-seaweed product that is produced via a lactic acid bacteria driven fermentation of canola (rape seed) and seaweed. The product is rich in glycosinolates and putatively prebiotic oligosaccharides, and it’s projected to have a huge impact on the human gut microbiota, and thereby human health.

The intervention study will be carried out as a double-blinded, placebo-controlled randomized controlled trial using a parallel design, with 100 obese participants consuming 5 grams/day of fermented seaweed and canola, or a rye cereal placebo. The participants will be instructed to maintain their daily routines throughout the six-week study, and thus potential changes would be mediated only by the supplement.

We will study the effects of the fermented canola-seaweed product on glucose handling and related cardiometabolic traits such as dyslipidemia and low-grade systemic inflammation. At each visit, an oral glucose tolerance test will be conducted to investigate insulin sensitivity by measuring 30- and 120-min blood glucose. Moreover, a small number of participants will also be included in a sub-study where they will have blood glucose levels monitored with a 24-hour continuous glucose monitoring for 14 days. We will also measure anthropometry and blood pressure. Finally, we will examine the gut microbiota and the metabolic phenotype of the subjects to explore molecular mechanisms related to the potential improvements.

Recruitment of participants is expected to begin in October 2019 and the final participants are expected to finish their trials in March 2020. The study will provide a better understanding of how a sustainable, fermented plant-based dietary supplement could be used as a potential supplement to alleviate obesity-related metabolic disorders in a population at high risk of developing type 2 diabetes and cardiovascular disease. Furthermore, the study will examine whether the product can affect obesity related metabolic disorders through modulation of the gut microbiota and host metabolome. We expect this study to enhance our insight into useful and valuable interventions for future development of microbiota-based interventions for patients with obesity and related metabolic disorders.

By: Mads Vendelbo Lind, Post-doc at the University of Copenhagen (