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

NCT07710274 | Not Yet Recruiting

• 1 other identifier: NUS-IRB-2026-0409
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome (MetS)

Outcome Measures

Primary Outcomes (1)

• Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as: HOMA-IR = (fasting plasma insulin × fasting plasma glucose) / 22.5 Higher HOMA-IR values indicate greater insulin resistance, whereas lower values indicate improved insulin sensitivity (reduced insulin resistance).

  At baseline, Week 10

Secondary Outcomes (55)

• Glycated haemoglobin (HbA1c) (%)

  At baseline, Week 10

• Fasting plasma glucose (mmol/L)

  At baseline, Week 10

• Fasting Insulin (µIU/mL)

  At baseline, Week 10

• Total cholesterol (mmol/L)

  At baseline, Week 10

• High-density lipoprotein cholesterol (HDL-C) (mmol/L)

  At baseline, Week 10

Study Arms (2)

Control

NO INTERVENTION

At baseline, participants will undergo blood collection, stool sample collection, questionnaires, and cognitive and physical assessments. They will be provided with an Oura Ring and continuous glucose monitor (CGM) to monitor physiological and behavioral measures throughout the study. Participants will use the eTRIP© app to log meals and the Oura app to record physical activity. General healthy lifestyle information on diet, physical activity, and sleep will be provided at baseline. Participants assigned to the control group will continue their usual lifestyle throughout the 10-week study and will not receive any targeted lifestyle intervention. At Week 5, participants will attend a study visit for interim assessments and replacement of the CGM for the remainder of the study. Baseline assessments will be repeated at Week 10.

PRISM

EXPERIMENTAL

At baseline, participants will undergo blood collection, stool sample collection, questionnaires, and cognitive and physical assessments. They will be provided with an Oura Ring and continuous glucose monitor (CGM) to monitor physiological and behavioural measures throughout the study. Participants will use the eTRIP© app to log meals and the Oura app to record physical activity. General healthy lifestyle advice on diet, physical activity, and sleep will be provided at baseline. At the end of the 2-week baseline assessment, participants will be randomized to one of four lifestyle interventions: time-restricted eating, increased physical activity, a low-glycemic load diet, or sleep hygiene. At Week 5, participants will attend a study visit and be randomized to receive an additional intervention from one of the remaining three lifestyle domains, beginning in Week 6. Baseline assessments will be repeated at Week 10.

Behavioral: Time-restricted eating; Behavioral: Physical Activity; Behavioral: Low Glycemic Load diet; Behavioral: Sleep hygiene

Interventions

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).

PRISM

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).

PRISM

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).

PRISM

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).

PRISM

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, 117597, Singapore

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jocelyn Chew

CONTACT

+6565168687; dbi-lab@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will complete a 2-week baseline assessment before randomization. Participants will then be randomized to one of four lifestyle intervention domains (dietary timing, dietary composition, physical activity, or sleep health) or to a control group. Participants assigned to an intervention group will receive their allocated intervention for the subsequent 4 weeks. At Week 6, they will be randomly assigned a second lifestyle intervention domain, which will be added to their existing intervention for the remainder of the study. Participants in the control group will remain in the control group throughout the study and will not receive any additional interventions. This pilot study is designed to assess the feasibility of the intervention procedures, study protocol, and delivery of sequential lifestyle interventions.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)