Time-restricted eating in patients with metabolic syndrome: A protocol paper for a feasibility clinical trial.

The TRE intervention restricts all calorie intake to a 10-hour eating window followed by a 14-hour fasting period without altering diet quality or quantity.

• The intervention duration is 12 weeks.
• The protocol does not require changes to diet quality or quantity, only timing of eating.
• This approach is described as a 'behavioral dietary intervention.'
• The intervention is positioned as a strategy to decrease cardiometabolic risk in metabolic syndrome without requiring traditional dietary modification.

The study uses a single-arm pilot feasibility design enrolling 40 adult patients with metabolic syndrome.

• Total enrollment target is 40 adult participants diagnosed with metabolic syndrome.
• The design is a single-arm group (no control group).
• The study is described as a 'pilot feasibility study.'
• Participants document their daily eating patterns through the MyCap app.

The primary outcome is to assess feasibility and acceptability of the TRE intervention across multiple dimensions.

• Feasibility domains include recruitment, program delivery, adherence, and patient satisfaction.
• The study acknowledges that 'dietary lifestyle changes can decrease risk in metabolic syndrome, but such changes are difficult to implement and sustain.'
• Acceptability is included as a co-primary outcome alongside feasibility.

Secondary outcome measures include a broad range of cardiometabolic, biological, and patient-reported outcomes.

• Secondary outcomes include changes in weight and blood pressure.
• Sleep and quality of life are included as patient-reported secondary outcomes.
• Biological measures include gut microbiome, HbA1c, lipids, and thyroid function.
• The inclusion of gut microbiome assessment is noted as a novel component of the study.

The authors note that existing studies evaluating TRE for weight loss and cardiometabolic risk factor improvement have produced mixed results.

• TRE is described as 'a promising dietary behavioral intervention for weight loss and cardiometabolic risk factor improvement.'
• The authors explicitly state 'the results are mixed' in prior TRE studies.
• The pilot study is intended to provide 'novel insights into improving information health markers in individuals with metabolic syndrome.'
• Findings are also intended to 'inform the feasibility and sustainability of this dietary intervention.'