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)

Author(s):  
Yunyi Tian ◽  
Yue Ma ◽  
Yuanqing Fu ◽  
Ju-Sheng Zheng

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

2020 ◽  
Vol 4 (9) ◽  
Author(s):  
Yunyi Tian ◽  
Yue Ma ◽  
Yuanqing Fu ◽  
Ju-Sheng Zheng

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).


2019 ◽  
Vol 123 (6) ◽  
pp. 664-672
Author(s):  
Elaine Wan Yi Peh ◽  
Katie Koecher ◽  
Ravi Menon ◽  
Christiani Jeyakumar Henry

AbstractBreakfast consumption is associated with a variety of nutritional and lifestyle-related health outcomes. The objective of the present study was to investigate how the consumption of breakfast affected blood glucose, insulin and NEFA profiles. A lower postprandial blood glucose, insulin and NEFA response is associated with a lower risk of development of metabolic diseases. In a randomised crossover non-blind design, thirteen pre-diabetic Chinese adult males (BMI 26·7 (sd 4·2) kg/m2) attended two sessions where they either consumed a high-glycaemic index breakfast or no breakfast consumption. Changes in glycaemic response over 27 h periods were measured using the Medtronic MiniMed iProTM2 continuous glucose monitoring system. Blood samples were collected using a peripheral venous catheter at fixed intervals for 3 h after the test meal and 3 h after standardised lunch consumption. Postprandial glucose, insulin and NEFA response was calculated as total AUC and incremental AUC using the trapezoidal rule that ignored the area under the baseline. It was found that breakfast consumption significantly decreased postprandial glucose, insulin and NEFA excursion response at lunch time (P = 0·001). Consumption of breakfast attenuated blood glucose profiles by minimising glycaemic excursions and reduced both insulinaemic and NEFA responses in pre-diabetic Asian males during the second meal. This simple dietary intervention may be a novel approach to help improve subsequent lunch glycaemic responses in Asians at high risk of developing diabetes.


Nutrients ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2374
Author(s):  
Risa Araki ◽  
Takeshi Yamada ◽  
Kazushi Maruo ◽  
Akihiro Araki ◽  
Rena Miyakawa ◽  
...  

We evaluated the suppressive effects of high-gamma-polyglutamic acid (γ-PGA) natto on postprandial blood glucose level and insulin response. After confirming the eligibility of candidates using a pre-selective test with packaged white rice, a meal loading test including low- or high-γ-PGA natto (with 57.6 mg (LPGA) and 439.6 mg (HPGA) of γ-PGA, respectively) was conducted in men aged 20 to 70 years (n = 29) and postmenopausal women aged ≤70 years (n = 7). On each examination day, blood samples were obtained after they fasted overnight and for 120 min after test meal loading. The primary outcome of this study was the difference between the measurements of the incremental area under the curve (IAUC) for blood glucose 0 to 30 min after loading of LPGA and HPGA meals. The IAUCs for blood glucose and insulin after the HPGA meal were lower than those after the LPGA meal within 45 min (0 to 15 and 0 to 30 min: p < 0.001, 0 to 45 min: p < 0.01) and 1 h (all p < 0.001) of loading, respectively. The suppressive effects of HPGA natto on postprandial glucose response in the early phase, which possibly relates to the risk of dysglycemia and cardiovascular disease, were clarified.


2001 ◽  
Vol 85 (1) ◽  
pp. 33-40 ◽  
Author(s):  
R. Giacco ◽  
F. Brighenti ◽  
M. Parillo ◽  
M. Capuano ◽  
A. V. Ciardullo ◽  
...  

The present study was aimed at evaluating in patients with type 2 diabetes: (1) the glycaemic response to four starchy foods based on wheat, typical of the Italian diet; (2) the importance of some food characteristics in relation to their effects on postprandial glucose response. Seventeen patients with type 2 diabetes (eleven men and six women) participated in the study. All patients consumed, in random order and on alternate days, 50 g available carbohydrate provided by 90 g white bread and, according to a randomised procedure, an equivalent amount of carbohydrate provided by one (n 8) or two (n 9) of three other different test foods (g): pizza 85, potato dumplings 165, hard toasted bread 60. Foods had a similar nutrient composition. Plasma glucose response, measured for 180 min, was significantly lower after the potato dumplings than after white bread at 90 (P<0·05), 120 (P<0·01) and 150 (P<0·05) min. No difference was observed in postprandial plasma insulin response after the various test foods. The percentage of starch hydrolysed after 5 h in vitro hydrolysis with α-amylase was about 30 % lower for potato dumplings than for the other foods. However, no differences in the resistant starch content, the rate of diffusion of simple sugars added to a dialysis tube containing the food, and the viscosity of digesta were observed among the test foods. Scanning electron microscopy of potato dumplings showed a compact structure compatible with impaired accessibility of starch to digestive enzymes. In conclusion, carbohydrate-rich foods typical of the Italian diet which are often consumed as an alternative to pasta dishes are not equivalent in terms of metabolic impact in diabetic patients. Due to their low blood glucose response, potato dumplings represent a valid alternative to other starchy foods in the diabetic diet. Food structure plays an important role in determining starch accessibility to digestion, thus influencing the postprandial blood glucose response.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Yannian Wang ◽  
Fenfen Wei ◽  
Changqing Sun ◽  
Quanzhong Li

Diabetes may result in some complications and increase the risk of many serious health problems. The purpose of clinical treatment is to carefully manage the blood glucose concentration. If the blood glucose concentration is predicted, treatments can be taken in advance to reduce the harm to patients. For this purpose, an improved grey GM (1, 1) model is applied to predict blood glucose with a small amount of data, and especially in terms of improved smoothness it can get higher prediction accuracy. The original data of blood glucose of type 2 diabetes is acquired by CGMS. Then the prediction model is established. Finally, 50 cases of blood glucose from the Henan Province People’s Hospital are predicted in 5, 10, 15, 20, 25, and 30 minutes, respectively, in advance to verify the prediction model. The prediction result of blood glucose is evaluated by the EGA, MSE, and MAE. Particularly, the prediction results of postprandial blood glucose are presented and analyzed. The result shows that the improved grey GM (1, 1) model has excellent performance in postprandial blood glucose prediction.


2017 ◽  
Vol 8 (10) ◽  
pp. 3783-3791 ◽  
Author(s):  
D. Dan Ramdath ◽  
Qiang Liu ◽  
Elizabeth Donner ◽  
Aileen Hawke ◽  
Danusha Kalinga ◽  
...  

Using human studies we confirm that lentils lower blood glucose response, which is correlated to the rapidly digestible starch and resistant starch content.


Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1839 ◽  
Author(s):  
Joto Yoshimoto ◽  
Yukiko Kato ◽  
Masayasu Ban ◽  
Mikiya Kishi ◽  
Humitoshi Horie ◽  
...  

Legumes are low-carbohydrate food and are abundant in dietary fiber. In order to provide a functional staple food that does not cause a rapid increase in postprandial blood glucose levels, four kinds of legumes were focused on as ingredients. Noodles made from dehulled yellow pea, unshelled yellow pea, chickpea, and lentil were prepared and evaluated as functional staple foods for controlling blood glucose via an in vitro digestion method. We also measured breaking stress and breaking strain using a creep meter, as well as sensory tests on a 9-point hedonic scale. The noodles made from yellow pea had high values for both breaking stress and breaking strain, and was highly regarded in the sensory tests. Therefore, the noodles made from yellow pea on postprandial glucose and insulin response were measured in a randomized double-blind study (n = 12). The results show that noodles made from yellow pea have a low glycemic index (50.4), and have potential as a functional staple food.


1994 ◽  
Vol 71 (5) ◽  
pp. 675-685 ◽  
Author(s):  
Christine Cherbut ◽  
S. Bruley Des Varannes ◽  
M. Schnee ◽  
Martine Rival ◽  
J-P. Galmiche ◽  
...  

Three dietary fibres with different physicochemical properties were studied in healthy humans for their effects on small intestinal motility and postprandial hyperglycaemia. Duodeno-jejunal motor activity was evaluated electromyographically for 180 min in six subjects who had ingested a test meal composed of glucose alone or glucose with 15 g of wheat bran (WB), sugar beet (SB) or ispaghula (I) fibres. Glucose and insulin concentrations were determined during the same period. Each subject received each of the four test meals randomly during a 4 d period. Addition of SB or I to the glucose meal altered duodeno-jejunal motility. Both of these fibres inhibited stationary contractile activity and increased the propagation length and velocity of propagated activity, whereas addition of WB had no effect. These results could reflect the high water-holding capacity of SB and 1. Blood glycaemic response to the glucose meal was reduced by SB and I but remained unchanged with WB. Postprandial blood glucose levels were significantly correlated with the total motility index (r 0·82) and stationary activity (r 0·79). Taken together, these observations suggest that the contractile activity induced by dietary fibre in the small intestine probably plays a major role in delayed glucose absorption.


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