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The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota

University of Alberta · 2019
ClinicalTrials.gov · Datasets · License: Public Domain · 2019
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body-compositionenergy-metabolismgut-microbiotainflammationna
This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compositional shifts within the gut microbiota. Moreover, resting energy expenditure, body composition, appetite sensations and soy metabolomics will be explored. This study will be a randomized, parallel group, clinical trial of a 12-week nutritional intervention. A sample size of n=88 participants will be randomly allocated into one of the following groups: * Control group (CON): Participants will be asked to maintain their usual dietary intake over 12 weeks. Their usual dietary intake is expected to reflect the North American dietary pattern (i.e. \~15% of total energy intake coming from protein, \~50% from carbohydrate and \~35% from fat). * Powdered Meal Replacement group (PMR): Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the meal replacement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The following variables will be analyzed: * Interleukin (IL)-6. * Gut microbiota diversity and composition, specifically taxa that have been associated with health benefits, obesity, and weight loss. * Systemic inflammatory biomarkers (high-sensitivity C-reactive protein, IL-8, IL-10 and tumor necrosis factor-α); * Metabolic blood markers (glucose, insulin, lipid panel, peptide tyrosine-tyrosine, glucagon-like peptide-1, ghrelin, adiponectin, leptin, free glycerol, free fatty acids, and thyroid stimulating hormone) * Resting energy expenditure; * Body composition; * Appetite sensations (hunger, satiety, fullness, and prospective food consumption); * Soy polyphenols' metabolomic
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