None listed
Conditions
Brief summary
The prevalence of type 2 diabetes (T2D) is increasing globally, and Mexico is at the forefront of this disease. Uncontrolled T2D is associated with long-term microvascular complications, such as nephropathy, neuropathy, retinopathy, or cardiovascular disease. Thus, strict glucose management is required for these patients. Among the strategies to achieve this goal is the adoption of modifications in lifestyle. In this line, resistant starch (RS) supplementation has been shown to decrease the glycemic response. However, the effects of RS on glycemic variability (GV), postprandial lipemia, or appetite are not well understood. We will conduct a randomized, crossover study to determine the effects of RS from two sources on GV, postprandial lipids, and appetite sensations in subjects with T2D. We will analyze the GV using the continuous glucose monitoring system (CGMS) during the intervention phase. During this period, we will perform a meal tolerance test (MTT) to analyze glycemic and insulinemic responses, as well as, appetite sensations. We hypothesized that RS supplementation could reduce GV, glycemic response, postprandial lipemia and have a positive influence on subjective appetite scores.
Interventions
During each treatment phase of a crossover design, the following will be performed. On day 1, a continuous glucose monitoring system (CGMS) sensor will be inserted by an endocrinologist in the peri-umbilical area to evaluate interstitial glucose every fifth minute. From days 1 to 4, each participant will consume two daily beverages containing one of three different supplements for the randomly assigned treatment.
The three treatment arms are listed as follows:
1. Digestible maize starch (DMS) c
During each treatment phase of a crossover design, the following will be performed. On day 1, a continuous glucose monitoring system (CGMS) sensor will be inserted by an endocrinologist in the peri-umbilical area to evaluate interstitial glucose every fifth minute. From days 1 to 4, each participant will consume two daily beverages containing one of three different supplements for the randomly assigned treatment. The three treatment arms are listed as follows: 1. Digestible maize starch (DMS) containing Amioca (Ingredion). 2. High amylose maize starch (HMS) containing Hi-Maize 260 (Ingredion). 3. Native banana starch (NBS) containing NBS and Amioca. All supplements will be matched by available carbohydrates (26.6 g), and the content of resistant starch (RS) in both HMS and NBS will be 40 g each. Beverages will be consumed at fasting state (7:00- 9:00 AM) and with lunch (13:00-15:00 PM). The study product will be provided in individual packaged, ready-to-use sachets to be mixed with a favorite drink in the blender at home. Compliance will be assessed by counting unopened sachets and by a query regarding the missed servings.
Sponsors
Universidad Juárez Autónoma de Tabasco
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with type 2 diabetes (T2D) previously diagnosed according to the American Diabetes Association. 2. Aged 25-60. Both males and females. 3. Body Mass Index (BMI) > 25 kg/m2. 4. Type 2 diabetic with glycosylated hemoglobin (HbA1c) over 6.5%, Under treatment with oral medication such as glibenclamide and/or metformin or lifestyle control.
Exclusion criteria
1. Smoking or alcohol intake. 2. Presence of cardiovascular, renal, hepatic or gastrointestinal disease (Crohn´s disease, colitis, gastroenteritis, celiac disease, short bowel syndrome). 3. Use of any medication with insulin, glitazones, DPP4 inhibitors, GLP -1 analogues, or other drugs that alter the absorption of monosaccharides, such as acarbose. 4. Have some form of psychiatric treatment. 5. Pregnant or breast-feeding females. 6. Practice physical exercise for more than 4 h a week. 7. Have non-permeable veins.
Outcome results
None listed