scholarly journals Application of n-of-1 Clinical Trials in Personalized Nutrition Research: A Trial Protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR)

2020 ◽  
Vol 4 (9) ◽  
Author(s):  
Yunyi Tian ◽  
Yue Ma ◽  
Yuanqing Fu ◽  
Ju-Sheng Zheng
Keyword(s):  
Dietary Intervention ◽  
Population Level ◽  
Postprandial Blood Glucose ◽  
Macronutrient Intake ◽  
Dietary Recommendations ◽  
Carbohydrate Diet ◽  
Glucose Response ◽  
Low Carbohydrate Diet ◽  
Nutrition Research ◽  
The Individual

ABSTRACT Personalized dietary recommendations can help with more effective disease prevention. This study aims to investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both the individual level and population level, and explore the potential of the novel single-patient (n-of-1) trial for personalization of diet. Secondary outcomes include individual phenotypic responses and the effects of dietary ingredients on the composition of gut microbiota. Westlake N-of-1 Trials for Macronutrient Intake is a multiple crossover feeding trial consisting of 3 successive 12-d dietary intervention pairs including a 6-d washout period before each 6-d isocaloric dietary intervention: a 6-d high-fat, low-carbohydrate diet, and a 6-d low-fat, high-carbohydrate diet. The results will help provide personalized dietary recommendations for macronutrients in terms of postprandial blood glucose responses. The proposed n-of-1 trial methods could help in optimizing individual health and advancing health care. This trial was registered with clinicaltrials.gov (NCT04125602).

scholarly journals Application of n-of-1 clinical trials in personalized nutrition research: a trial protocol for Westlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR)

2020 ◽  
Author(s):  
Yunyi Tian ◽  
Yue Ma ◽  
Yuanqing Fu ◽  
Ju-Sheng Zheng
Keyword(s):  
Blood Glucose ◽  
Dietary Intervention ◽  
Postprandial Glucose ◽  
Postprandial Blood Glucose ◽  
Individual Response ◽  
Macronutrient Intake ◽  
Feeding Trial ◽  
Glucose Response ◽  
Food Ingredients ◽  
Link Type

AbstractBACKGROUNDDiet and nutrition play essential roles in human health. Personalized dietary recommendations or nutritional advice tailored to each individual can help with more effective disease prevention. N-of-1 trials can provide a pragmatic clinical means of addressing individual postprandial blood glucose variation in response to different food ingredients or nutrients.OBJECTIVETo investigate the individual postprandial glucose response to diets with diverse macronutrient proportions at both individual level and population level and the potential of the novel single-patient (n-of-1) trial for the personalization of diet.DESIGNWestlake N-of-1 Trials for Macronutrient Intake (WE-MACNUTR) is a multiple crossover feeding trial. Individual response to different dietary patterns in terms of postprandial glucose response is the primary outcome. Secondary outcomes include individual phenotypic response and the effects of dietary ingredients on the composition and structure of gut microbiota.SETTINGParticipants experience three successive 12-day dietary intervention pairs including a 6-day wash-out period before each isocaloric dietary intervention. Two different type of diets (a 6-day high-fat, low-carbohydrate (HF-LC) diet and a 6-day low-fat, high-carbohydrate (LF-HC) diet) are assigned to an individual in a randomized sequence using block randomization with a fixed block size of two. This feeding trial takes place in Hangzhou, China.PARTICIPANTSTarget enrolment is 30 healthy individuals aged between 18 and 65 years. Exclusion criteria are inability or unwillingness to approved informed consent; other serious medical conditions; food allergy; and no access to a smart phone or computer with an internet connection.DISCUSSIONThis trial addresses the feasibility of n-of-1 approach for personalizing dietary intervention to individuals. The results will help provide personalized dietary recommendation on macronutrients in terms of postprandial blood glucose response. Well-designed n-of-1 trial is likely to become an effective method of optimizing individual health and advancing health care.TRIAL REGISTRATIONClinicalTrials.gov identifier: NCT04125602

Interim analysis of a prospective randomized trial of dietary carbohydrate restriction for men with a rising PSA after failed primary treatment: Carbohydrate and Prostate Study 2 (CAPS2).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 382-382
Author(s):  
Stephen J. Freedland ◽  
Jenifer Allen ◽  
Andrew J. Armstrong ◽  
Judd W. Moul ◽  
Howard M. Sandler ◽  
...  
Keyword(s):  
Weight Loss ◽  
Interim Analysis ◽  
Dietary Intervention ◽  
Local Treatment ◽  
Carbohydrate Restriction ◽  
Dietary Carbohydrate ◽  
Carbohydrate Diet ◽  
Curative Intent ◽  
Low Carbohydrate Diet ◽  
Low Carbohydrate

382 Background: Nearly one third of men treated with curative intent for localized prostate cancer (PC) will develop a rising PSA. The rate of PSA rise (PSA doubling time aka PSASDT) is a predictor metastases and PC death. In laboratory mice, an extreme low carbohydrate diet slows PC growth. We tested whether this diet could slow PSADT in men with recurrent PC. Methods: We are conducting a 6-month multi-center randomized phase II trial of dietary carbohydrate restriction vs. no diet intervention control. Men had to have a BMI ≥24 kg/m2, received radical prostatectomy or definitive local radiation for PC, had a PSA 0.4-20.0 ng/ml (3-20 if prior radiation therapy) within the past 3 months, and current PSADT 3-36 months. The intervention arm was instructed to eat < 20 grams/carbs/day with no other limits. The control arm was told to make no diet. In this interim analysis, we present the efficacy of the dietary intervention with regards to weight loss. Arms were compared using rank-sum. Total anticipated enrollment is 60. The primary outcome is differences in PSADT between arms. Secondary outcomes include weight loss, and dietary make-up. Results: To date, 28 patients (14 in each study arm) have completed the study. Characteristics were well-balanced at baseline. At the 6-month dietary assessment, calorie consumption was similar between the two study arms (p = 0.090) among the 16 patients (7 low-carb, 9 control) with diet information. Subjects in the low-carb arm ate fewer carbs (29 vs. 188 g, p = 0.008) and more protein (125 vs. 73 g, p = 0.044) but similar amounts of fat (75 vs. 67 g, p = 0.672) vs. subjects in the control arm. Six months on the low carb diet resulted in greater weight loss (median: 31.7 vs. 0.8 lbs, p < 0.001), lower BMI (24.4 vs. 29.6 kg/m2, p < 0.001), and smaller waist circumference (95.7 vs. 108.9 cm, p = 0.002). Conclusions: In this interim analysis of an on-going dietary study for men with a rising PSA after definitive local treatment, an extreme low carbohydrate diet results in dramatic weight loss in 6 months. Whether this weight loss slows PC growth is an on-going question. Clinical trial information: NCT01763944.

Slow postmeal walking reduces postprandial glycemia in middle-aged women

2009 ◽  
Vol 34 (6) ◽  
pp. 1087-1092 ◽  
Author(s):  
Håvard Nygaard ◽  
Sissel Erland Tomten ◽  
Arne Torbjørn Høstmark
Keyword(s):  
Blood Glucose ◽  
Glucose Concentration ◽  
Blood Glucose Concentration ◽  
Negative Relationship ◽  
Postprandial Blood Glucose ◽  
Moderate Intensity ◽  
Glucose Response ◽  
Postprandial Glycemia ◽  
Blood Glucose Response ◽  
The Individual

Postprandial blood glucose concentration is a risk factor for the development of cardiovascular diseases and diabetes, even at states well below hyperglycemic levels. A previous study has shown that postmeal exercise of moderate intensity blunts the blood glucose increase after carbohydrate intake (Høstmark et al. Prev. Med. 42(5): 369–371). The objective of the present study was to examine whether even postmeal slow walking would have a similar effect. Fourteen healthy women aged >50 years participated in 3 experiments in a random crossover design: after a carbohydrate-rich meal, either they were seated (control experiment) or they performed slow postmeal walking for 15 min (W15) or 40 min (W40). Blood glucose concentration was determined prior to the meal (fasting), and at 11 time points throughout each experiment. The W15 trial lowered the blood glucose values during walking and delayed the peak blood glucose value (p = 0.003). In W40, the postmeal blood glucose increase during walking was blunted, the peak glucose value was delayed (p = 0.001), and the incremental area under the 2-h blood glucose curve (IAUC) was reduced (p = 0.014). There was a negative relationship between IAUC and walking time (p = 0.016). The individual reducing effect of walking on IAUC correlated strongly with IAUC on the control day (p < 0.001). We conclude that even slow postmeal walking can reduce the blood glucose response to a carbohydrate-rich meal. The magnitude of this effect seems to be related to the duration of walking and to the magnitude of the postprandial blood glucose response when resting after a carbohydrate-rich meal.

scholarly journals Glucose response to low-dose glucagon for insulin-induced mild hypoglycaemia after 12 weeks of high versus low carbohydrate diet. A pilot study

2020 ◽  
Author(s):  
Ajenthen G. Ranjan ◽  
Signe Schmidt ◽  
Jens J. Holst ◽  
Merete B. Christensen ◽  
Kirsten Nørgaard
Keyword(s):  
Low Dose ◽  
Insulin Pump ◽  
Random Order ◽  
Fasting State ◽  
Carbohydrate Diet ◽  
Glucose Response ◽  
Low Carbohydrate Diet ◽  
Mild Hypoglycaemia ◽  
Low Carbohydrate

AbstractObjectiveTo compare the glucose response to low-dose glucagon after high carbohydrate diet (HCD) versus low carbohydrate diet (LCD).MethodsIndividuals with insulin pump-treated type 1 diabetes went through 12 weeks of HCD (>250 g/day) and 12 weeks of LCD (<100 g/day) in random order and separated by 12 weeks. At end of each diet, mild hypoglycaemia was induced in the fasting state by a subcutaneous insulin bolus. When plasma glucose (PG) reached 3.9 mmol/L, 100 µg glucagon was given subcutaneously.ResultsFour of six participants completed both study visits while the remaining two only completed the study visit following LCD. They were 37 (28-52) years old (median (IQR)), had BMI 25.0 (24.5-25.2) kg/m2, and HbA1c 57 (55-59) mmol/mol or 7.4 (7.2-7.5) %. Daily carbohydrate intake was 95 (86-97) g during LCD and 254 (184-259) g during HCD. Compared with HCD, LCD had a significantly lower area under the PG curve from 0-120 min (521 (394-617) vs 663 (546-746) mmol/l x min, p=0.045) and insignificant lower incremental PG peak after the glucagon bolus (1.5 (0.6-3.2) vs 3.0 (2.2-4.2) mmol/L, p=0.317).ConclusionIn conclusion, the glucose response to low-dose glucagon was reduced after 12 weeks of LCD compared with HCD.

scholarly journals Effect of Soya based Protein Rich Diet on Glycaemic Parameters and Thyroid Function Tests in Women with Gestational Diabetes Mellitus

2016 ◽  
Vol 23 (2) ◽  
pp. 201-208 ◽  
Author(s):  
Vijaya Sarathi ◽  
Anish Kolly ◽  
Hulivana Boranna Chaithanya ◽  
Chinthamani Suryanarayana Dwarakanath
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Dietary Intervention ◽  
Postprandial Blood Glucose ◽  
Complex Carbohydrate ◽  
Carbohydrate Diet ◽  
High Fiber ◽  
Protein Rich

AbstractBackground and Aims: Medical nutrition therapy plays a major role in the management of gestational diabetes mellitus (GDM). However, control of postprandial blood glucose values is often a challenge in Asian Indian GDM women due to high carbohydrate content in Indian diet.Materials and Methods: Women presenting with GDM diagnosis were randomised to high fiber complex carbohydrate diet and soya based protein rich diet (25% of cereal part in the high fiber, complex carbohydrate diet replaced by soya food) groups.Results: At the end of one week after initiation of dietary intervention, patients who received high fiber complex carbohydrate diet (n=30) had significantly higher postprandial blood glucose levels than those who received soya based protein rich diet (n=32). The need for insulin therapy at the end of one week after initiation of dietary intervention (15.62% vs. 40.0%) and at delivery (18.75% vs. 50%) were significantly lower in soya based protein rich diet group. Maternal thyroid function at diagnosis of GDM and delivery and neonatal TSH were not significantly different between the groups.Conclusion: Consumption of soya based protein rich diet reduced the need for insulin therapy in subjects with GDM. Short term consumption of soya food did not alter maternal and neonatal thyroid functions.

scholarly journals Safety and efficacy of very low carbohydrate diet in patients with diabetic kidney disease—A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258507
Author(s):  
Nur Aisyah Zainordin ◽  
Nur’ Aini Eddy Warman ◽  
Aimi Fadilah Mohamad ◽  
Fatin Aqilah Abu Yazid ◽  
Nazrul Hadi Ismail ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Diabetic Kidney Disease ◽  
Dietary Intervention ◽  
Carbohydrate Diet ◽  
Diabetic Kidney ◽  
Renal Outcomes ◽  
Low Carbohydrate Diet ◽  
Randomized Controlled ◽  
Low Protein ◽  
Low Carbohydrate

Introduction There is limited data on the effects of low carbohydrate diets on renal outcomes particularly in patients with underlying diabetic kidney disease. Therefore, this study determined the safety and effects of very low carbohydrate (VLCBD) in addition to low protein diet (LPD) on renal outcomes, anthropometric, metabolic and inflammatory parameters in patients with T2DM and underlying mild to moderate kidney disease (DKD). Materials and methods This was an investigator-initiated, single-center, randomized, controlled, clinical trial in patients with T2DM and DKD, comparing 12-weeks of low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet. Patients in the VLCBD group underwent 2-weekly monitoring including their 3-day food diaries. In addition, Dual-energy x-ray absorptiometry (DEXA) was performed to estimate body fat percentages. Results The study population (n = 30) had a median age of 57 years old and a BMI of 30.68kg/m2. Both groups showed similar total calorie intake, i.e. 739.33 (IQR288.48) vs 789.92 (IQR522.4) kcal, by the end of the study. The VLCBD group showed significantly lower daily carbohydrate intake 27 (IQR25) g vs 89.33 (IQR77.4) g, p<0.001, significantly higher protein intake per day 44.08 (IQR21.98) g vs 29.63 (IQR16.35) g, p<0.05 and no difference in in daily fat intake. Both groups showed no worsening of serum creatinine at study end, with consistent declines in HbA1c (1.3(1.1) vs 0.7(1.25) %) and fasting blood glucose (1.5(3.37) vs 1.3(5.7) mmol/L). The VLCBD group showed significant reductions in total daily insulin dose (39(22) vs 0 IU, p<0.001), increased LDL-C and HDL-C, decline in IL-6 levels; with contrasting results in the control group. This was associated with significant weight reduction (-4.0(3.9) vs 0.2(4.2) kg, p = <0.001) and improvements in body fat percentages. WC was significantly reduced in the VLCBD group, even after adjustments to age, HbA1c, weight and creatinine changes. Both dietary interventions were well received with no reported adverse events. Conclusion This study demonstrated that dietary intervention of very low carbohydrate diet in patients with underlying diabetic kidney disease was safe and associated with significant improvements in glycemic control, anthropometric measurements including weight, abdominal adiposity and IL-6. Renal outcomes remained unchanged. These findings would strengthen the importance of this dietary intervention as part of the management of patients with diabetic kidney disease.

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