Digitally enhanced ketogenic diet versus low‐fat diet for cardio‐renal‐metabolic health in a predominantly Hispanic adult population with overweight or obesity: Pilot randomised clinical trial
Authors' conclusion
Digitally enhanced lifestyle intervention was feasible. Both diets, enhanced by digital tools, were efficacious in weight reduction. The ketogenic diet showed potential benefits for glycaemic and BP control. Metabolite changes reflect sensitive responses to lifestyle interventions. Further research is warranted to explore the integration of digital tools and metabolic data for developing personalised lifestyle interventions.
Study context
- Population
- Adults living with overweight or obesity; 58.3% Hispanic
- Participants
- 60 adults
- Comparison
- Digitally enhanced ketogenic diet vs low-fat diet
- Ketogenic dietn = 30
- Low-fat dietn = 30reference
- Primary endpoint
- Feasibility and preliminary efficacy
Methodological detailspilot
- Pilot
Primary result
As reported in the abstract
Enrolled planned sample size within 1 year despite COVID-19-related challenges
N = 60
Retention at 3 months
73.3%
Retention at 6 months
71.7%
Further findings
| Outcome | B (95% CI) | P value |
|---|---|---|
| Ketone levels · 3 monthsSignificantly higher in ketogenic group · intention-to-treat analysis; linear mixed models | 0.2 (0.05–0.35) | P = 0.015 |
Feasibility: enrolment and retention · 3 and 6 months
- Planned sample size enrolled within 1 year despite COVID-19-related challenges
- N = 60
- Retention at 3 months
- 73.3%
- Retention at 6 months
- 71.7%
Ketone levels · 3 months
- No significant differences in other clinical or metabolic outcomes between groups
Weight and BMI · 3 and 6 months
- Both groups showed significant weight and BMI reductions
HbA1c, ketogenic group (within-group) · baseline, 3 and 6 months
- HbA1c improved only in ketogenic group; baseline
- 6.0 ± 0.9%
- 3-month
- 5.5 ± 0.7%, p < 0.001
- 6-month
- 5.7 ± 0.8%, p = 0.004
Systolic blood pressure (BP), ketogenic group (within-group) · 3 months
- Systolic BP improved in ketogenic group
- 131.2 ± 12.9 to 123.1 ± 11.2, p = 0.006
Targeted metabolites (e.g., isoleucine, leucine), within both groups · 3 and 6 months
- Decreased significantly from baseline to 3 months
- ≈21/29 metabolites
- Decreased significantly from baseline to 6 months
- ≈22/29 metabolites
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →