A package containing a mix of functional foods
Dietary SupplementParticipants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein and genistein.
NCT Number: NCT05230342
This study will investigate whether changes in the intestinal microbiota generated through a nutritional strategy based on functional foods, modifies postprandial glycemic responses in subjects with prediabetes and obesity, which in turn will generate a personalized dietary intervention through a prediction of postprandial blood glucose levels.
This study is active but is not currently recruiting participants.
18 year–60 year
All sexes
Interventional
Not applicable
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
The increase in postprandial blood glucose constitutes a global epidemic and an important risk factor for the development of prediabetes and type 2 diabetes (T2D). Prediabetes is characterized by alterations in blood glucose concentrations and is considered an important risk factor for the development of T2D, considering that 70% of subjects with prediabetes will eventually develop the disease. Therefore, maintaining normal blood glucose concentrations is considered a critical point to prevent and control the development of T2D, mainly through lifestyle changes. In addition, the elevated postprandial glycemic responses (PPGRs) are an independent risk factor for the development of T2D and are associated with the presence of obesity.
Dietary intake is a central determinant of blood glucose concentrations therefore to maintain these concentrations within normal values, it is important to make adequate decisions regarding food, to induce a normal PPGRs. There are several methods to control the PPGRs such as the carbohydrate count which depends on the phenotypic characteristics of the patient. Other methods aimed at estimating the PPGRs like the glycemic index, which quantifies the PPGR derived from the consumption of a single type of food already tested, having limited applicability in the evaluation of the PPGR in real life where food is a set of different types and amounts of food, which are consumed at different times of the day under different conditions of sleep, physical activity and other activities of daily life that alter glucose concentrations.
Studies have shown inter and intrapersonal differences in PPGRs after consuming the same amount of the same food. Factors that can affect interpersonal differences in PPGRs include genetics, lifestyle, and insulin sensitivity. Another factor that may be involved is the gut microbiota.
The objective of this study is to evaluate whether the changes in the intestinal microbiota generated through a nutritional strategy based on functional foods, modifies postprandial glycemic responses in subjects with prediabetes and obesity, which in turn may generate a personalized dietary intervention through a prediction of postprandial blood glucose levels by an algorithm based-diet. This nutritional strategy consists of providing a set of functional foods such as nopal, chia, soy, inulin and the isoflavone genistein, since there is evidence that these foods lower blood glucose concentrations and modify the intestinal microbiota. A clinical trial will be conducted with 100 adults with prediabetes and obesity who meet the inclusion criteria. These patients will be divided into two groups of 50 each and their glucose will be continuously monitored with a continuous glucose monitor which will be taking glucose concentrations every 15 min. The patients will have one of two treatments; placebo or nutritional strategy with functional foods. They will be determined before and after monitoring: anthropometric and biochemical parameters, food consumption, physical activity, lifestyle, metabolites in urine as well as determination of the composition of the intestinal microbiota.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be provided with a nutritional strategy based on functional foods to use over the 2 week trial. These will be nopal, chía seeds, inulin, soy protein and genistein.
The control group will receive a comparable set of food items that contain an equivalent number of calories per portion but without the added functional ingredients
Time frame: 2 weeks
Compare the effect between a nutritional strategy based on functional foods and the placebo group on postprandial glycemic response in subjects with obesity
Time frame: 2 weeks
Total daily interstitial glucose levels will be evaluated by using Continuous glucose monitoring (CGM).
Time frame: 2 weeks
Determine if changes in the composition of intestinal microbiota after the consumption of a nutritional strategy based on functional foods modify the postprandial glycemic response in subjects with obesity.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
Personalized Nutrition Based on the Glycemic Response: Effect of Diet and Intestinal
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