A technology assisted precision ketogenic diet intervention for cardio-renal-metabolic health in overweight or obese adults: Protocol for a randomized controlled trial

Yan Du, Jing Wang, Shiyu Li, Brittany Dennis, Christiane Meireles, Nazishi Siddiqui, Darpan Patel, John Gelfond, Chengdong Li, Syed Hasib Akhter Faruqui, Adel Alaeddini, Viktor Drel, Jana Tumova, Hongping Ye, Richard Montellano, Gustavo Armaiz-Pena, Kumar Sharma

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Article number106845
JournalContemporary Clinical Trials
Volume119
DOIs
StatePublished - Aug 2022

Keywords

  • Cardio-renal-metabolic health
  • Ketogenic diet
  • Metabolomics
  • Mitochondrial function
  • Omics
  • Overweight and obese
  • Precision health

ASJC Scopus subject areas

  • Pharmacology (medical)

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