Metabolic Syndrome (MetS)PRISM-INCT07710274
Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
A study testing Time-restricted eating, Physical Activity and Low Glycemic Load diet in people with Metabolic Syndrome (MetS), run by National University Health System, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Metabolic Syndrome (MetS)
- What is being tested?
- Time-restricted eating, Physical Activity and Low Glycemic Load diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore, 117597
About this study
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.
Read the detailed description
Specific objectives are to:
- Evaluate the feasibility and acceptability of the PRISM intervention and study procedures, including participant recruitment, retention, adherence, intervention delivery, and digital platform usability.
- Explore the preliminary effects of the four lifestyle interventions (time-restricted eating, increased physical activity, low-glycaemic load diet, and sleep hygiene) on insulin resistance, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
- Examine the preliminary effects of the interventions on biochemical, anthropometric, behavioural, cognitive, and psychological outcomes.
- Explore the potential behavioural and physiological pathways through which the lifestyle interventions may influence insulin resistance to inform the design of the definitive PRISM trial.
- Conditions
- Metabolic Syndrome (MetS)
- Being tested
- Time-restricted eating, Physical Activity, Low Glycemic Load diet, Sleep hygiene
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
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 ActivityBehavioural
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 dietBehavioural
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 hygieneBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Time-restricted eating; Behavioral: Physical Activity; Behavioral: Low Glycemic Load diet; Behavioral: Sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, Week 10
Secondary outcomes (55)
Glycated haemoglobin (HbA1c) (%)
Glycated haemoglobin (HbA1c) reflects average blood glucose levels over the preceding two to three months and is measured using standard laboratory blood analysis. Higher values indicate poorer long-term glycaemic control.
Measured: At baseline, Week 10
Fasting plasma glucose (mmol/L)
Fasting blood glucose is a biochemical measure of blood glucose concentration after an overnight fast, measured using standard laboratory blood analysis. Higher values indicate poorer glycaemic control.
Measured: At baseline, Week 10
Fasting Insulin (µIU/mL)
Fasting plasma insulin is a biochemical marker measured using standard laboratory blood analysis following an overnight fast. Higher values indicate greater insulin resistance and impaired glucose metabolism.
Measured: At baseline, Week 10
Total cholesterol (mmol/L)
Total cholesterol is a lipid biomarker measured using standard laboratory blood analysis to assess overall blood cholesterol levels. Higher values indicate poorer lipid profiles and increased cardiometabolic risk.
Measured: At baseline, Week 10
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
High-density lipoprotein cholesterol (HDL-C) is a lipid biomarker measured using standard laboratory blood analysis to assess protective cholesterol levels. Lower values indicate poorer lipid profiles and increased cardiometabolic risk.
Measured: At baseline, Week 10
Low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Low-density lipoprotein cholesterol (LDL-C) is a lipid biomarker measured using standard laboratory blood analysis to assess atherogenic cholesterol levels. Higher values indicate poorer lipid profiles and increased cardiovascular risk.
Measured: At baseline, Week 10
Cholesterol/HDL ratio
The total cholesterol to HDL cholesterol ratio is calculated from standard laboratory blood analysis and is used to assess cardiovascular risk. Higher values indicate a poorer lipid profile and increased cardiometabolic risk.
Measured: At baseline, Week 10
Triglycerides (mmol/L)
Triglycerides are a lipid biomarker measured using standard laboratory blood analysis to assess circulating triglyceride levels. Higher values indicate poorer lipid profiles and increased cardiometabolic risk.
Measured: At baseline, Week 10
Lipoprotein a (nmol/L)
Lipoprotein(a) is an advanced lipid biomarker measured using standard laboratory blood analysis to assess inherited cardiovascular risk. Higher values are associated with increased risk of atherosclerotic cardiovascular disease
Measured: At baseline, Week 10
Apolipoprotein A1 (g/L)
Apolipoprotein A1 (ApoA1) is a lipid biomarker measured using standard laboratory blood analysis to assess the major protein component of HDL cholesterol. Higher values generally indicate a more favourable lipid profile.
Measured: At baseline, Week 10
Apolipoprotein B (g/L)
Apolipoprotein B (ApoB) is a lipid biomarker measured using standard laboratory blood analysis to assess the number of atherogenic lipoprotein particles. Higher values indicate increased cardiovascular risk.
Measured: At baseline, Week 10
Apolipoprotein B/ A1 ratio
The Apolipoprotein B/A1 ratio is calculated from standard laboratory blood analysis and reflects the balance between atherogenic and protective lipoproteins. Higher values indicate increased cardiovascular risk
Measured: At baseline, Week 10
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
High-sensitivity C-reactive protein (hs-CRP) is an inflammatory biomarker measured using standard laboratory blood analysis to assess low-grade systemic inflammation. Higher values indicate greater systemic inflammation and increased cardiometabolic risk.
Measured: At baseline, Week 10
Total protein (g/L)
Total protein is measured using standard laboratory blood analysis to assess the combined concentration of albumin and globulins in blood.
Measured: At baseline, Week 10
Albumin (g/L)
Albumin is a plasma protein measured using standard laboratory blood analysis to assess nutritional status and liver function. Lower values may indicate impaired liver function, malnutrition, or inflammation.
Measured: At baseline, Week 10
Globulin (g/L)
Globulin is measured using standard laboratory blood analysis to assess immune and inflammatory proteins in the blood.
Measured: At baseline, Week 10
A/G ratio
The albumin-to-globulin (A/G) ratio is calculated from serum albumin and globulin concentrations and is used to assess liver function, nutritional status, and inflammatory conditions.
Measured: At baseline, Week 10
Bilirubin (µmol/L)
Bilirubin is measured using standard laboratory blood analysis to assess liver function and bilirubin metabolism.
Measured: At baseline, Week 10
Alkaline phosphatase (ALP) (U/L)
Alkaline phosphatase (ALP) is a liver enzyme measured using standard laboratory blood analysis to assess liver and biliary tract function.
Measured: At baseline, Week 10
Alanine aminotransferase (ALT/SGPT) (U/L)
Alanine aminotransferase (ALT/SGPT) is a liver enzyme measured using standard laboratory blood analysis to assess liver cell injury.
Measured: At baseline, Week 10
Aspartate aminotransferase (AST/SGOT) (U/L)
Aspartate aminotransferase (AST/SGOT) is a liver enzyme measured using standard laboratory blood analysis to assess liver and muscle cell injury. Higher values may indicate liver damage or other tissue injury.
Measured: At baseline, Week 10
Blood pressure (mmHg)
Both systolic and diastolic blood pressure will be assessed.
Measured: At baseline, Week 10
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a validated screening instrument designed to detect mild cognitive impairment. It assesses multiple cognitive domains, including attention and concentration, executive function, memory, language, visuospatial skills, abstraction, calculation, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: At baseline, Week 10
Hand grip strength (kg)
Hand grip strength will be measured using a Jamar dynamometer as an indicator of muscle strength. Higher values indicate greater muscle strength.
Measured: At baseline, Week 10
Weight (kg)
Measured: At baseline, Weeks 5,10
Waist circumference (cm)
Measured: At baseline, Weeks 5,10
Body mass index (BMI) (kg/m²)
Body mass index (BMI) will be calculated as weight (kg)/height² (m²). Lower values indicate lower overall adiposity.
Measured: At baseline, Weeks 5,10
Percentage Body Fat (%)
Percentage body fat will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate lower adiposity.
Measured: At baseline, Weeks 5,10
Body Fat Mass (kg)
Measured using InBody 120.
Measured: At baseline, Weeks 5,10
Visceral Fat Level
Visceral fat level will be estimated using bioelectrical impedance analysis (InBody 120). Lower values indicate reduced visceral adiposity.
Measured: At baseline, Week 10
ABSI (body shape index)
A Body Shape Index (ABSI) is calculated from waist circumference, height, and body weight to assess central adiposity independently of BMI. Higher values indicate greater abdominal obesity and cardiometabolic risk.
Measured: At baseline, Weeks 5,10
BRI (body roundness index)
Body Roundness Index (BRI) is calculated from height and waist circumference to estimate body fat distribution and central adiposity. Higher values indicate greater abdominal adiposity and cardiometabolic risk.
Measured: At baseline, Weeks 5,10
Three Factor Eating Questionnaire (TFEQ)
The Three-Factor Eating Questionnaire-Revised 18 is a validated self-administered instrument used to assess eating-related behaviours. It measures three domains: cognitive restraint, uncontrolled eating, and emotional eating. Scores are calculated separately for each domain and transformed to a 0-100 scale, with higher scores indicating greater levels of the respective eating behaviour.
Measured: At baseline, Week 10
International Physical Activity Questionnaire Short-Form (IPAQ-SF)
The International Physical Activity Questionnaire - Short Form is a validated self-administered questionnaire used to assess self-reported physical activity levels over the previous 7 days. It captures the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and time spent sitting. Responses are used to calculate total physical activity expressed as MET-minutes/week. There is no fixed minimum or maximum score; higher MET-minutes/week indicate higher levels of physical activity.
Measured: At baseline, Week 10
Generalized Anxiety Disorder 7-item (GAD-7)
The Generalized Anxiety Disorder 7-item questionnaire is a validated self-administered screening instrument used to assess the frequency of anxiety symptoms over the previous 2 weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: At baseline, Week 10
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 is a validated self-administered screening instrument used to assess the frequency of depressive symptoms over the previous 2 weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: At baseline, Week 10
Perceived Stress Scale (PSS-10)
The Perceived Stress Scale-10 is a validated self-administered questionnaire used to assess the degree to which individuals perceive situations in their lives as stressful over the previous month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: At baseline, Week 10
Big Five Inventory - 44 item (BFI-44)
The Big Five Inventory-44 is a validated self-administered questionnaire used to assess personality across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism. Scores are calculated separately for each domain; there is no overall total score. Domain scores are typically calculated as the mean of the items within each domain and range from 1 to 5, with higher scores indicating greater expression of the respective personality trait. As this is a descriptive measure of personality, higher scores do not represent universally better or worse outcomes.
Measured: At baseline, Week 10
Sleep Hygiene Index (SHI)
The Sleep Hygiene Index is a validated 13-item self-administered questionnaire that assesses behaviours associated with sleep hygiene. Total scores range from 13 to 65, with higher scores indicating poorer sleep hygiene practices.
Measured: At baseline, Week 10
Gut microbiome
Measured: At baseline, Week 10
Resting heart rate (beats/min)
Resting heart rate measured using the Oura Ring. Resting heart rate represents the average heart rate during periods of rest. Lower values generally indicate better cardiovascular fitness.
Measured: Baseline through Week 10
Heart rate variability (ms)
Heart rate variability measured using the Oura Ring. HRV reflects variation in the time interval between successive heartbeats and is an indicator of autonomic nervous system function. Higher values generally indicate better autonomic regulation and recovery.
Measured: Baseline through Week 10
Heart rate recovery (beats/min)
Heart rate recovery measured using the Oura Ring. Heart rate recovery represents the reduction in heart rate following physical activity and reflects cardiovascular recovery capacity. Higher values indicate faster recovery and better cardiovascular fitness.
Measured: Baseline through Week 10
Sleep duration (hours)
Sleep duration measured using the Oura Ring. Sleep duration represents the total amount of sleep obtained per night. Higher values generally indicate longer sleep duration.
Measured: Baseline through Week 10
Sleep quality score (0-100)
Sleep quality score measured using the Oura Ring. Scores range from 0 to 100, with higher scores indicating better sleep quality.
Measured: Baseline through Week 10
Daily step count (steps/day)
Daily step count measured using the Oura Ring. Step count represents the total number of steps accumulated per day. Higher values indicate greater daily physical activity.
Measured: Baseline through Week 10
Activity intensity minutes (minutes/day)
Activity intensity minutes measured using the Oura Ring. This metric represents the daily duration of moderate-to-vigorous physical activity. Higher values indicate greater participation in physical activity.
Measured: Baseline through Week 10
Energy expenditure (kcal/day)
Energy expenditure measured using the Oura Ring. This metric represents the estimated daily energy expenditure from physical activity. Higher values indicate greater energy expenditure.
Measured: Baseline through Week 10
Mean glucose (mmol/L)
Mean glucose concentration measured using continuous glucose monitoring. Mean glucose represents the average glucose concentration over the monitoring period. Lower values generally indicate better glycaemic control.
Measured: Baseline through Week 10
Coefficient of variation (%)
Coefficient of variation of glucose measured using continuous glucose monitoring. CV reflects glucose variability relative to mean glucose concentration. Lower values indicate more stable glucose levels and better glycaemic control.
Measured: Baseline through Week 10
Time Below Range (TBR, %)
Percentage of time spent below the target glucose range (<3.9 mmol/L), measured using continuous glucose monitoring. Lower values indicate less time spent in hypoglycaemia and better glycaemic control.
Measured: Baseline through Week 10
Time In Range (TIR, %)
Percentage of time spent within the target glucose range (3.9-10.0 mmol/L), measured using continuous glucose monitoring. Higher values indicate better glycaemic control.
Measured: Baseline through Week 10
Time Above Range (TAR, %)
Percentage of time spent above the target glucose range (>10.0 mmol/L), measured using continuous glucose monitoring. Lower values indicate less hyperglycaemia and better glycaemic control.
Measured: Baseline through Week 10
Postprandial glucose excursion (PPGE) (mmol/L)
Postprandial glucose excursion measured using continuous glucose monitoring. PPGE is calculated as the difference between peak glucose concentration and pre-meal glucose concentration within 2 hours after the start of a meal. Higher values indicate greater postprandial glucose excursions.
Measured: Baseline through Week 10
Incremental Area Under the Curve (iAUC, mmol/L·min)
Incremental area under the glucose curve measured using continuous glucose monitoring. iAUC represents the area under the glucose curve above the pre-meal baseline during the 2-hour period following a meal. Higher values indicate greater overall postprandial glucose exposure.
Measured: Baseline through Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start17 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Chew, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710274
- Sponsor's protocol ID
- NUS-IRB-2026-0409
- Acronym
- PRISM-I
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Personalized Responses & Integrated Systems for Metabolism (PRISM) on Improving Insulin Resistance Among Adults With Metabolic Syndrome: A Pilot Study (PRISM-I)
- ClinicalTrials.gov ID
- NCT07710274
- Acronym / sponsor ID
- PRISM-I / NUS-IRB-2026-0409
- Conditions
- Metabolic Syndrome (MetS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific objectives are to:
- Evaluate the feasibility and acceptability of the PRISM intervention and study procedures, including participant recruitment, retention, adherence, intervention delivery, and digital platform usability.
- Explore the preliminary effects of the four lifestyle interventions (time-restricted eating, increased physical activity, low-glycaemic load diet, and sleep hygiene) on insulin resistance, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
- Examine the preliminary effects of the interventions on biochemical, anthropometric, behavioural, cognitive, and psychological outcomes.
- Explore the potential behavioural and physiological pathways through which the lifestyle interventions may influence insulin resistance to inform the design of the definitive PRISM trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Time-restricted eating, Behavioral: Physical Activity, Behavioral: Low Glycemic Load diet, Behavioral: Sleep hygieneAt 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingFollowing 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). | Behavioural | PRISM |
| Physical ActivityFollowing 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). | Behavioural | PRISM |
| Low Glycemic Load dietFollowing 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). | Behavioural | PRISM |
| Sleep hygieneFollowing 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). | Behavioural | PRISM |
Primary outcome
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: At baseline, Week 10
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).
55 secondary outcomes
Glycated haemoglobin (HbA1c) (%)
Time frame: At baseline, Week 10
Fasting plasma glucose (mmol/L)
Time frame: At baseline, Week 10
Fasting Insulin (µIU/mL)
Time frame: At baseline, Week 10
Total cholesterol (mmol/L)
Time frame: At baseline, Week 10
High-density lipoprotein cholesterol (HDL-C) (mmol/L)
Time frame: At baseline, Week 10
Low-density lipoprotein cholesterol (LDL-C) (mmol/L)
Time frame: At baseline, Week 10
Cholesterol/HDL ratio
Time frame: At baseline, Week 10
Triglycerides (mmol/L)
Time frame: At baseline, Week 10
Lipoprotein a (nmol/L)
Time frame: At baseline, Week 10
Apolipoprotein A1 (g/L)
Time frame: At baseline, Week 10
Apolipoprotein B (g/L)
Time frame: At baseline, Week 10
Apolipoprotein B/ A1 ratio
Time frame: At baseline, Week 10
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Time frame: At baseline, Week 10
Total protein (g/L)
Time frame: At baseline, Week 10
Albumin (g/L)
Time frame: At baseline, Week 10
Globulin (g/L)
Time frame: At baseline, Week 10
A/G ratio
Time frame: At baseline, Week 10
Bilirubin (µmol/L)
Time frame: At baseline, Week 10
Alkaline phosphatase (ALP) (U/L)
Time frame: At baseline, Week 10
Alanine aminotransferase (ALT/SGPT) (U/L)
Time frame: At baseline, Week 10
Aspartate aminotransferase (AST/SGOT) (U/L)
Time frame: At baseline, Week 10
Blood pressure (mmHg)
Time frame: At baseline, Week 10
Montreal Cognitive Assessment (MoCA)
Time frame: At baseline, Week 10
Hand grip strength (kg)
Time frame: At baseline, Week 10
Weight (kg)
Time frame: At baseline, Weeks 5,10
Waist circumference (cm)
Time frame: At baseline, Weeks 5,10
Body mass index (BMI) (kg/m²)
Time frame: At baseline, Weeks 5,10
Percentage Body Fat (%)
Time frame: At baseline, Weeks 5,10
Body Fat Mass (kg)
Time frame: At baseline, Weeks 5,10
Visceral Fat Level
Time frame: At baseline, Week 10
ABSI (body shape index)
Time frame: At baseline, Weeks 5,10
BRI (body roundness index)
Time frame: At baseline, Weeks 5,10
Three Factor Eating Questionnaire (TFEQ)
Time frame: At baseline, Week 10
International Physical Activity Questionnaire Short-Form (IPAQ-SF)
Time frame: At baseline, Week 10
Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: At baseline, Week 10
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At baseline, Week 10
Perceived Stress Scale (PSS-10)
Time frame: At baseline, Week 10
Big Five Inventory - 44 item (BFI-44)
Time frame: At baseline, Week 10
Sleep Hygiene Index (SHI)
Time frame: At baseline, Week 10
Gut microbiome
Time frame: At baseline, Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating, Physical Activity and Low Glycemic Load diet in people with Metabolic Syndrome (MetS), run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyn Chew (+6565168687, dbi-lab@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: At baseline, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.