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Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)

Sponsor: National University Health System, Singapore • ClinicalTrials.gov ID: NCT07710274

Registry updated: 2026-09-25

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Description

The primary objective of the Personalized Responses \& Integrated Systems for Metabolism (PRISM-I) pilot study is to assess the feasibility of conducting a definitive randomized controlled trial evaluating precision lifestyle interventions for improving insulin resistance in adults with metabolic syndrome.

Interventions

Time-restricted eating (Behavioral)
Following a 2-week baseline assessment, participants will begin a time-restricted eating (TRE) intervention by consuming all meals within a self-selected 8-hour eating window and fasting for the remaining 16 hours each day. They will measure blood ketone levels daily before breaking their fast using a glucometer. At Week 6, participants will be randomly assigned an additional lifestyle intervention (physical activity, low glycemic load diet, or sleep hygiene).
Physical Activity (Behavioral)
Following a 2-week baseline assessment, participants will begin a physical activity intervention. They will be instructed to complete home-based resistance training three times per week and aerobic interval training twice per week using a guided exercise programme. Exercise sessions will be performed independently without direct supervision. Participants will also be encouraged to aim for at least 8,000 steps daily, take a 15-minute walk after lunch and dinner where feasible, and break up prolonged sitting every 30-60 minutes with light movement or standing. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, low-glycemic load diet, or sleep hygiene).
Low Glycemic Load diet (Behavioral)
Following a 2-week baseline assessment, participants will begin a low-glycaemic load (GL) diet intervention. They will be instructed to replace high-GL foods with lower-GL alternatives, reduce their intake of refined carbohydrates, sugary foods and beverages, and ultra-processed foods, and follow healthy meal composition and meal sequencing principles. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, physical activity, or sleep hygiene).
Sleep hygiene (Behavioral)
Following a 2-week baseline assessment, participants will begin a sleep hygiene intervention. They will be instructed to adopt healthy sleep habits, including maintaining a regular sleep schedule with adequate sleep duration, practicing good bedtime routines, and optimizing the sleep environment to improve sleep quality. At Week 6, participants will be randomly assigned an additional lifestyle intervention (time-restricted eating, physical activity, or a low-glycemic load diet).

Eligibility criteria

Inclusion Criteria: Participants will be included for if they are: * (1) adults aged 21-70 years old; * (2) willing and able to comply with using a CGM, smart ring, food logging app * (3) able to provide written informed consent; * (4) English-speaking and literate; * (5) meet the inclusion criteria for metabolic syndrome and insulin resistance. * The criteria for insulin resistance is HOMA-IR ≥ 2.5. * The criteria for metabolic syndrome is to have high waist circumference (≥ 80cm for females and ≥ 90cm for males); and any two of the four below: * (1) raised triglycerides: 1.7 mmol/L or on treatment; * (2) reduced HDL cholesterol: \< 1.0 mmol/L (40 mg/dL) in men, \< 1.3 mmol/L (50 mg/dL) in women, or on treatment; * (3) high blood pressure: 130/85 mmHg or on treatment; or * (4) raised fasting glucose: 5.6 mmol/L (100 mg/dL) or previously diagnosed with T2DM Exclusion Criteria: Participants will be excluded from both phases if they are: * (1) on insulin therapy; * (2) are pregnant or lactating; * (3) have a medical condition or are on a treatment that may interfere with study participation or metabolic assessments, as determined by the study investigators; * (4) currently participating in other lifestyle modification programs.

Conditions

Metabolic Syndrome (MetS)

Locations

National University of Singapore — Singapore, Singapore

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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