METHODS: We evaluated the effects of a novel natural food adjuvant combining mulberry leaf extract (MLE) with other bioactive ingredients, in people with type 2 diabetes (T2D) originating from Asia, on improving PP glucometabolic response in a randomized controlled exploratory crossover, two-center study (USA, Singapore). A 2-g blend of 250 mg MLE [containing 12.5 mg of 1-deoxynojirimycin (DNJ)], fiber (1.75 g), vitamin D3 (0.75 μg), and chromium (75 μg), compared with a similar blend without the MLE, was sprinkled over a 350-kcal breakfast meal (55.4 g carbs) and PP blood glucose (primary exploratory endpoint), insulin, and incretin hormones (GLP-1, GIP) were evaluated in blood samples over 3 h. Changes in incremental areas under the concentration curve (iAUC) and maximum concentrations (Cmax) were compared.
RESULTS: Thirty individuals (12 women, mean age 59 years, HbA1c 7.1%, BMI 26.5 kg/m2) were enrolled and the MLE-based blend relative to the blend without MLE significantly reduced glucose iAUC at 1 h (- 20%, p
OBJECTIVE: This study aims to assess the effectiveness of the Malaysian Geriatric Patients' Hospital Foodservice Protocol (MYGERYFS).
METHODS: The protocol comprises 3 phases. Phase One is a cross-sectional study that took place at public hospitals with geriatric wards in the Klang Valley. Univariate data from Phase One were analyzed descriptively. Pearson correlation and chi-square were conducted to find factors associated with foodservice satisfaction. Phase Two involves the collaboration of health care professionals in the geriatric field. In Phase Three, a feasibility study will be conducted to determine the feasibility of the MYGERYFS protocol in a hospital among 60 geriatric patients. These patients will be randomized into control and intervention groups, respectively. Intervention care will be done to ensure the safety of the protocol.
RESULTS: Data collection for Phase One of the study has been completed. A total of 233 geriatric respondents with the mean age of 71.39 (SD 7.99) years were gathered. Approximately 51.5% (n=120) of the respondents were female, while 48.5% (n=113) were male, with a mean BMI of 24.84 (SD 6.05) kg/m2. Their mean energy and protein intakes were 1006.20 kcal (SD 462.03 kcal) and 42.60 (SD 22.20) grams, respectively. Based on the Mini Nutritional Assessment, older patients who scored 12-14 (normal) were 27.9% (n=65), those who scored 8-11 (at risk) were 54.9% (n=128), and those who scored 0-7, which is the lowest (malnutrition), were 17.2% (n=40) of the study population. Hence, most patients were at risk of malnutrition. Although a majority of the patients claimed to have good foodservice satisfaction 26.2% (n=61), they also experienced at least 3 barriers during mealtimes. It was found that dietary intake and mealtime barriers were significantly associated with the respondent's foodservice satisfaction. Data for Phase Two and Phase Three are yet to be collected and analyzed.
CONCLUSIONS: This study protocol could potentially benefit the hospital foodservice system and aid in improving geriatric nutritional status.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04858165; https://clinicaltrials.gov/ct2/show/NCT04858165.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/42496.
MATERIALS AND METHODS: This cross-sectional study was conducted on 124 breast cancer outpatients within the first year of diagnosis and yet to commence oncological treatment. Body composition parameters [body weight, body mass index (BMI), body fat percentage, fat mass over fat-free mass ratio (FM/FFM), muscle mass, and visceral fat] were obtained using a bioelectrical impedance analyzer. Body fat percentage was categorized into two groups which were normal (<35%) and high (≥35%). The E-DII was calculated from the validated 165-items Food Frequency Questionnaire (FFQ) and categorized into three groups or tertiles. Multiple logistic regression analysis was used to determine the association between the E-DII and body fat percentage.
RESULTS: Mean body weight, body fat percentage, FM/FFM, and visceral fat increased as E-DII increased from the lowest tertile (T1) to the most pro-inflammatory tertile (T3) (p for trend <0.05). E-DII was positively associated with body fat percentage (OR 2.952; 95% CI 1.154-7.556; p = 0.024) and remained significant after adjustment for cancer stage, age, physical activity, ethnicity, smoking history, and presence of comorbidities. Compared to T1, participants in T3 had a significantly lower consumption of fiber, vitamin A, beta-carotene, vitamin C, iron, thiamine, riboflavin, niacin, vitamin B6, folic acid, zinc, magnesium, and selenium, but a higher intake of total fat, saturated fat, and monounsaturated fatty acids.
CONCLUSIONS: A higher E-DII was associated with increased body fat percentage, suggesting the potential of advocating anti-inflammatory diet to combat obesity among newly diagnosed breast cancer patients.
OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.
METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).
RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.
CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.
SUBJECTS/METHODS: This study included 259 pregnant women within the Seremban Cohort Study (SECOST). Blood samples at < 14 weeks of gestation were drawn to determine serum 25(OH)D levels. GDM diagnosis was made at 24 to 32 weeks of gestation using a standard procedure. Association between serum vitamin D and GDM was tested using binary logistic regression.
RESULTS: Nearly all women (90%) had mild (68.3%) or severe (32.2%) vitamin D deficiency (VDD). Non-GDM women with mild VDD had a significantly higher mean vitamin D intake than GDM women with mild VDD (t = 2.04, p < 0.05). Women with higher early pregnancy serum vitamin D levels had a greater risk of GDM. However, this significant association was only identified among those with a family history of type 2 diabetes mellitus (T2DM) and in women with a body mass index indicating overweight or obese status.
CONCLUSIONS: The high prevalence of VDD in this sample of pregnant women underscores the need for effective preventive public health strategies. Further investigation of this unexpected association between serum vitamin D level and GDM risk in predominantly VDD pregnant women and the potential effects of adiposity and family history of T2DM on that association is warranted.
METHODS: This was an 8-week, parallel-group, non-randomised study of 60 type 2 diabetes patients who opted for structured Ramadan Nutrition Therapy (sRNT; n = 38) or standard care (SC; n = 22) group. The sRNT group received a structured Ramadan Nutrition Plan incorporated with diabetes-specific formula throughout the study, while SC received standard nutrition care. The 3-day food records assessed dietary intake at three-time points.
RESULTS: At baseline, dietary characteristics were comparable; both groups had macronutrient intakes within the recommended range, but inadequate intakes of fiber and 11 essential micronutrients. After 8 weeks, the sRNT group significantly reduced intakes of carbohydrate, dietary glycemic index, glycemic load, and increased percentage of total energy intake from protein, fiber, pyridoxine, vitamin C, vitamin D, calcium, and chromium compared with the SC group. In the sRNT group, compliance to diabetes-specific formula predicted changes in HbA1c (p = 0.024), while fiber intake predicted fasting plasma glucose (p = 0.035), after adjusting for age, sex, weight changes and other dietary variables.
CONCLUSION: Intakes of certain nutrients improved significantly in sRNT group after 8 weeks of receiving a structured Ramadan Nutrition Plan compared to the standard care. The structured Ramadan Nutrition Plan with the incorporation of diabetes-specific formula significantly improved glycemic control and dietary adequacy during Ramadan fasting.
METHODS: We performed a systematic search using PubMed, Scopus, Cochrane Library, Web of Science for randomised controlled trials (RCTs), published until March 17, 2021. The quality assessment was carried out using the Cochrane Collaboration risk of bias tool. The Q-test and I 2 tests were used for the determination of heterogeneity of the included studies. Data were pooled using a random-effects model, and weighted mean difference (WMD) was used for the overall effect size.
RESULTS: Pooled findings of the five RCTs demonstrated that ginger supplementations had significantly reduced hs-CRP (WMD -0.42 mg/L; 95% CI, -0.78, -0.05, P = 0.03), TNF-α (-2.13 pg/mL; 95% CI: -3.41, -0.86, P = 0.001), and IL-6 (WMD: -0.61 pg/mL; 95% CI: -0.92, -0.30, P = 0.001) levels in patients with T2DM. The quality assessment of the studies showed that all of the included studies were at high risk of bias.
CONCLUSIONS: The meta-analysis shows that ginger supplementations reduced inflammatory parameters in patients with T2DM. Nonetheless, the reduction is relatively small, and its meaningful clinical effects are unknown. Future high-quality RCTs are needed to confirm the beneficial effects of ginger supplementation in patients with T2DM.
METHODS: This a randomized controlled trial (RCT) randomized 208 patients with T2DM [mean age = 48.8 ± 11.8 years, Glycated Hemoglobin (HbA1c) = 9.5 ± 2.4%, and Body Mass Index = 28.0 ± 5.6 kg/m2] to intervention group (n = 104) or control group (n = 104). Participants in the intervention group received a weekly diabetes nutrition module based on the health belief model for 12 weeks in addition to the usual care whereas the control participants were given the usual care. We evaluated HbA1c and diabetes-related outcomes (metabolic parameters, dietary intake, and physical activity level) at baseline, 12 weeks, and 22 weeks. Health beliefs, diabetes knowledge, and health literacy were also evaluated.
RESULTS: After 22 weeks, HbA1c improved significantly in the intervention group (-1.7%) from the baseline value, compared to the control group (+0.01%) (p
METHODS AND ANALYSIS: The study will be modelled according to the Capability, Opportunity, Motivation and Behaviour and Behaviour Change Wheel techniques, and use the DoTTI framework to identify needs, solutions and testing of a preliminary mobile app, respectively. In phase 1 (design and development), a focus group discussion (FGDs) of 5-8 individuals will be conducted with an estimated 60 women with GDM and 40 HCPs (doctors, dietitians and nurses). Synthesised data from the FGDs will then be combined with content from an expert committee to inform the development of the mobile app. In phase 2 (testing of early iterations), a preview of the mobile app will undergo alpha testing among the team members and the app developers, and beta testing among 30 women with GDM or with a history of GDM, and 15 HCPs using semi-structured interviews. The outcome will enable us to optimise an intervention using the mobile app as a diabetes prevention intervention which will then be evaluated in a randomised controlled trial.
ETHICS AND DISSEMINATION: The project has been approved by the Malaysia Research Ethics Committee. Informed consent will be obtained from all participants. Outcomes will be presented at both local and international conferences and submitted for publications in peer-reviewed journals.