TY - JOUR
T1 - A technology assisted precision ketogenic diet intervention for cardio-renal-metabolic health in overweight or obese adults
T2 - Protocol for a randomized controlled trial
AU - Du, Yan
AU - Wang, Jing
AU - Li, Shiyu
AU - Dennis, Brittany
AU - Meireles, Christiane
AU - Siddiqui, Nazishi
AU - Patel, Darpan
AU - Gelfond, John
AU - Li, Chengdong
AU - Faruqui, Syed Hasib Akhter
AU - Alaeddini, Adel
AU - Drel, Viktor
AU - Tumova, Jana
AU - Ye, Hongping
AU - Montellano, Richard
AU - Armaiz-Pena, Gustavo
AU - Sharma, Kumar
N1 - Publisher Copyright:
© 2022
PY - 2022/8
Y1 - 2022/8
N2 - Background: The obesity epidemic is a public health concern, as it is associated with a variety of chronic conditions. The ketogenic diet has drawn much scientific and public attention. However, implementation is challenging and its effect on cardio-renal-metabolic health is inconclusive. This study will assess the feasibility, acceptability, and preliminary efficacy of a technology-assisted ketogenic diet on cardio-renal-metabolic health. Methods: This is a single center, 6-month, stratified, randomized controlled trial. A total of 60 overweight/obese adults (18+ years old) will be enrolled, including 20 without type 2 diabetes (T2D) and without chronic kidney disease (CKD); 20 with T2D, but without CKD; and 20 with early-stage CKD. Participants will be stratified based on health conditions and randomized into a ketogenic diet (n = 30) or a low-fat diet group (n = 30). Health education involving diet and physical activity will be delivered both digitally and in-person. Mobile and connected health technologies will be used to track lifestyle behaviors and health indicators, as well as provide weekly feedback. The primary outcome (weight) and the secondary outcomes (e.g., blood pressure, glycemic control, renal health) will be assessed with traditional measurements and metabolomics. Discussion: Mobile and connected health technologies provide new opportunities to improve chronic condition management, health education attendance, planned lifestyle changes and engagement, and health outcomes. The advancement of bioinformatics technology offers the possibility to profile and analyze omics data which may advance our understanding of the underlying mechanisms of intervention effects on health outcomes at the molecular level for personalized and precision lifestyle interventions.
AB - Background: The obesity epidemic is a public health concern, as it is associated with a variety of chronic conditions. The ketogenic diet has drawn much scientific and public attention. However, implementation is challenging and its effect on cardio-renal-metabolic health is inconclusive. This study will assess the feasibility, acceptability, and preliminary efficacy of a technology-assisted ketogenic diet on cardio-renal-metabolic health. Methods: This is a single center, 6-month, stratified, randomized controlled trial. A total of 60 overweight/obese adults (18+ years old) will be enrolled, including 20 without type 2 diabetes (T2D) and without chronic kidney disease (CKD); 20 with T2D, but without CKD; and 20 with early-stage CKD. Participants will be stratified based on health conditions and randomized into a ketogenic diet (n = 30) or a low-fat diet group (n = 30). Health education involving diet and physical activity will be delivered both digitally and in-person. Mobile and connected health technologies will be used to track lifestyle behaviors and health indicators, as well as provide weekly feedback. The primary outcome (weight) and the secondary outcomes (e.g., blood pressure, glycemic control, renal health) will be assessed with traditional measurements and metabolomics. Discussion: Mobile and connected health technologies provide new opportunities to improve chronic condition management, health education attendance, planned lifestyle changes and engagement, and health outcomes. The advancement of bioinformatics technology offers the possibility to profile and analyze omics data which may advance our understanding of the underlying mechanisms of intervention effects on health outcomes at the molecular level for personalized and precision lifestyle interventions.
KW - Cardio-renal-metabolic health
KW - Ketogenic diet
KW - Metabolomics
KW - Mitochondrial function
KW - Omics
KW - Overweight and obese
KW - Precision health
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U2 - 10.1016/j.cct.2022.106845
DO - 10.1016/j.cct.2022.106845
M3 - Article
C2 - 35809772
AN - SCOPUS:85133882131
SN - 1551-7144
VL - 119
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106845
ER -