Aims/Introduction: Very few studies assess the effectiveness of different protocols of intermittent very-low calorie diet (VLCD) in patients with diabetes. This study was designed to compare the effects of 2 days/week and 4 days/week of intermittent VLCD on glycemic control, diabetes remission, metabolic parameters and quality of life in patients with type 2 diabetes and obesity. Materials and Methods: Participants with obesity and type 2 diabetes were recruited and randomly assigned to three groups, consisting of control, 2 days/week and 4 days/ week of intermittent VLCD. In the intermittent VLCD groups, participants received a 600kcal diet per day on restricted days and ad libitum food consumption on non-restricted days. Glycemic control, rate of diabetes remission, metabolic parameters and quality of life were evaluated at baseline, weeks 2, 10 and 20. Results: A total of 40 participants were enrolled. The mean body mass index was 30.1 -5.9 kg/m 2 , and the mean glycated hemoglobin was 7.4 -1.2%. At week 20, there was an improvement in glycemic control in both intermittent VLCD groups with significant decreases in glycated hemoglobin levels and insulin resistance index throughout the study periods. Diabetes remission without the need for medications was equally found in 29% of participants in both intermittent VLCD groups. Serum triglyceride, bodyweight, body mass index and fat mass were also significantly decreased in both VLCD groups. No serious adverse events were encountered. Conclusion: Intermittent VLCD was highly effective in achieving optimal glycemic control. The effects of 2 days/week and 4 days/week of intermittent VLCD on diabetes remission were relatively similar.
BACKGROUND Despite high risk of bacterial contamination, yet there are no studies that have evaluated the optimal hang time of blenderized and reconstituted powdered formulas at standard room temperature and high temperature. AIM To investigate the optimal hang time of both types of formulas at standard room temperature and high temperature. METHODS Ten specimens of blenderized formula and 10 specimens of reconstituted powdered formula were prepared using aseptic techniques. Five specimens of each formula were administered at 25 °C and 32 °C. Simulated administration was done in an incubator. The samples were collected at 0, 2, 4, 6 h and aerobic culture was performed. Food and drug administration criteria were used to determine the unacceptable levels of bacterial contamination. RESULTS Unacceptable contamination for blenderized formula began at 4 h at 25 °C and at 2 h at 32 °C. As for the reconstituted powdered formula, there was no bacterial growth in all specimens up to 6 h at both temperatures. CONCLUSION The optimal hang time to avoid significant bacterial contamination of the blenderized formula should be limited to 2 h at standard room temperature and be administered by bolus method at high temperature, while a reconstituted powdered formula may hang up to 6 h at both temperatures.
Aim: Intermittent very-low-calorie diet (VLCD) provides more flexibility than continuous VLCD to optimize individual results. This study was designed to determine the effects of Intermittent VLCD (2 or 4 days/week) on glycemic control, metabolic parameters and quality of life (QoL) in patients with type 2 diabetes and obesity. Method: 40 participants (mean age 49.6 ± 7.9 years, BMI 30.1 ± 5.9 kg/m2, mean diabetes duration 4.7 ± 3.1 years, mean HbA1C 7.4 ± 1.2%) were enrolled. Participants were randomly assigned 1:1:1 into 3 groups [control (n=12), 2 days/week VLCD (n=14), or 4 days/week VLCD (n=14)]. In the Intermittent VLCD groups, participants received 600 kcal/day in restricted days (2 and 4 non-consecutive days/week) and ad libitum food consumption on non-restricted days for 20 weeks. Metabolic parameters and QoL were evaluated at baseline, 2nd, 10th and 20th week. Results: There was improvement in glycemic control in both intermittent VLCD groups throughout the study period. At the end of study, an intention-to-treat analysis showed that the mean reduction (± SEM) of FPG level was 7.9 (± 13.5), 25.1 (± 12.5) and 39.7 (± 12.5) mg/dl, and HbA1C level was 0.1(± 1.3), 0.7 (± 0.3) and 1.2 (± 0.3) % in the control group, the 2 days/week VLCD group and the 4 days/week VLCD group, respectively. There were no significant differences in the reduction in FPG or HbA1c between the 2 days/week and 4 days/week VLCD groups. The mean difference (± SEM) of FPG level between both groups was 11 mg/dl (95% CI, -17.5 - 39.5 mg/dl) and the mean difference (± SEM) of HbA1C level between both groups was 0.39% (95% CI, -3.3 - 1.1%). Intermittent VLCD was associated with marked improvement in insulin sensitivity and beta-cell function, as reflected in HOMA-IR, Matsuda, Disposition, and Insulinogenic indices. QoL was significantly increased in all groups. Conclusion: Intermittent VLCD, 2 days/week or 4 days/week, was equally comparable and effective in achieving glycemic control. Disclosure M. Umphonsathien: None. P. Rattanasian: None. W. Suansawang: None. S. Lokattachariya: None. W. Khovidhunkit: None. Funding National Research Council of Thailand; Health Systems Research Institute
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