Trial Outcomes & Findings for The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome (NCT NCT04057339)
NCT ID: NCT04057339
Last Updated: 2026-07-30
Results Overview
Glycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Baseline and 14 weeks
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
SOC (Standard of Care)
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
TRE + SOC
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
COMPLETED
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
SOC (Standard of Care)
n=61 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
TRE + SOC
n=61 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
122 Participants
n=40 Participants
|
|
Age, Continuous
|
61.43 years
STANDARD_DEVIATION 9.17 • n=20 Participants
|
56.78 years
STANDARD_DEVIATION 11.34 • n=20 Participants
|
58.74 years
STANDARD_DEVIATION 10.94 • n=40 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
60 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=20 Participants
|
56 Participants
n=20 Participants
|
112 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Medications for treatment of metabolic syndrome
Metformin
|
3 participants
n=20 Participants
|
4 participants
n=20 Participants
|
7 participants
n=40 Participants
|
|
Medications for treatment of metabolic syndrome
Statins
|
31 participants
n=20 Participants
|
29 participants
n=20 Participants
|
60 participants
n=40 Participants
|
|
Medications for treatment of metabolic syndrome
Antihypertensives and diuretics
|
31 participants
n=20 Participants
|
28 participants
n=20 Participants
|
59 participants
n=40 Participants
|
|
Medications for treatment of metabolic syndrome
Nonstatin lipid-lowering drugs
|
2 participants
n=20 Participants
|
2 participants
n=20 Participants
|
4 participants
n=40 Participants
|
|
Medications for treatment of metabolic syndrome
1 or more medication listed
|
38 participants
n=20 Participants
|
46 participants
n=20 Participants
|
84 participants
n=40 Participants
|
|
Metabolic syndrome classification
HbA1c≥5.7 %, fasting glucose ≥5.55 mmol/L (100 mg/dL), or drug treatment
|
61 participants
n=20 Participants
|
61 participants
n=20 Participants
|
122 participants
n=40 Participants
|
|
Metabolic syndrome classification
HDL cholesterol: M <40 mg/dL or F < 50 mg/dL (F), or drug treatment of reduced HDL cholesterol
|
42 participants
n=20 Participants
|
44 participants
n=20 Participants
|
86 participants
n=40 Participants
|
|
Metabolic syndrome classification
Triglycerides ≥1.69 mmol/L (150 mg/dL), or drug treatment of elevated triglycerides
|
25 participants
n=20 Participants
|
25 participants
n=20 Participants
|
50 participants
n=40 Participants
|
|
Metabolic syndrome classification
SBP ≥130 mm Hg and/or DBP ≥85 mm Hg, or drug treatment of hypertension
|
44 participants
n=20 Participants
|
48 participants
n=20 Participants
|
92 participants
n=40 Participants
|
|
Metabolic syndrome classification
Waist circumference: Asian: ≥90 cm (M) or ≥80 cm (F); all other races: ≥102 cm (M) or ≥88 cm (F)
|
55 participants
n=20 Participants
|
52 participants
n=20 Participants
|
107 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksHbA1c (%)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Glucose Levels Assessed Via HbA1c
|
-0.12 percentage of HbA1c
Interval -0.19 to -0.05
|
-0.02 percentage of HbA1c
Interval -0.09 to 0.04
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksPopulation: n = 54 per group for all outcomes except for the CGM measurements: TRE, n = 52; SOC, n = 53.
Glycemic parameters assessed via fasting glucose (mg/dL)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Glycemic Parameters Assessed Via Fasting Glucose
|
-4.83 mg/dL
Interval -7.48 to -2.19
|
-1.50 mg/dL
Interval -4.54 to 1.54
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksGlycemic parameters assessed via HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) - a calculated index estimating insulin resistance from fasting blood glucose and insulin levels, using the formula (fasting glucose × fasting insulin) ÷ 405. Lower scores indicate healthier insulin sensitivity, while higher scores indicate greater insulin resistance.
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Glycemic Parameters Assessed Via HOMA-IR
|
-0.89 Index
Interval -1.93 to 0.05
|
-0.38 Index
Interval -1.07 to 0.31
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksGlycemic parameters assessed via fasting insulin (μIU/mL)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Glycemic Parameters Assessed Via Fasting Insulin
|
-2.88 μIU/mL
Interval -6.39 to 0.64
|
-1.21 μIU/mL
Interval -3.47 to 1.06
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksGlycemic parameters assessed via CGM mean glucose (mg/dL).
Outcome measures
| Measure |
TRE + SOC
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=53 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Glycemic Parameters Assessed Via CGM Mean Glucose
|
-2.26 mg/dL
Interval -5.27 to 0.75
|
1.98 mg/dL
Interval -1.33 to 5.3
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksGlycemic parameters assessed via CGM CONGA (Continuous Overall Net Glycemic Action)
Outcome measures
| Measure |
TRE + SOC
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=53 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Glycemic Parameters Assessed Via CGM CONGA
|
-1.47 mg/dL
Interval -2.53 to -0.41
|
0.06 mg/dL
Interval -0.99 to 1.11
|
PRIMARY outcome
Timeframe: Baseline and 14 weeksGlycemic parameters assessed via CGM MODD (mg/dL)
Outcome measures
| Measure |
TRE + SOC
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=53 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Glycemic Parameters Assessed Via CGM MODD
|
-1.89 mg/dL
Interval -2.89 to 0.88
|
0.53 mg/dL
Interval -0.58 to 1.64
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksPopulation: n = 52 per group (missing data due to laboratory error: interference)
LDL particle number (nmol/L) via NMR lipoprofile
Outcome measures
| Measure |
TRE + SOC
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in LDL Particle Number
|
-125.46 nmol/L
Interval -191.9 to -59.03
|
-48.00 nmol/L
Interval -104.64 to 8.64
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksLDL cholesterol (mg/dl)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in LDL Cholesterol
|
-10.48 mg/dl
Interval -15.83 to -5.13
|
-1.37 mg/dl
Interval -6.38 to 3.64
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksHDL cholesterol (mg/dl)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in HDL Cholesterol
|
-1.37 mg/dl
Interval -2.9 to 0.15
|
-0.37 mg/dl
Interval -1.98 to 1.24
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksTriglycerides (mg/dl)
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Triglycerides
|
-7.78 mg/dl
Interval -19.78 to 4.23
|
-13.94 mg/dl
Interval -26.17 to -1.82
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksLower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA).
Outcome measures
| Measure |
TRE + SOC
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=52 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Body Composition by DXA
|
-1.55 percentage of fat
Interval -7.87 to -0.9
|
-0.15 percentage of fat
Interval -0.83 to 0.53
|
SECONDARY outcome
Timeframe: Baseline and 14 weeksHigh sensitivity C-reactive protein (mg/L)
Outcome measures
| Measure |
TRE + SOC
n=53 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
SOC (Standard of Care)
n=54 Participants
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
|---|---|---|
|
Change in Hs-CRP
|
-0.19 mg/L
Interval -0.66 to 0.28
|
-0.09 mg/L
Interval -0.89 to 0.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 14 weeksMitochondrial structure and gene expression in skeletal muscle as assessed by skeletal muscle biopsies.
Outcome measures
Outcome data not reported
Adverse Events
SOC (Standard of Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRE + SOC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SOC (Standard of Care)
n=61 participants at risk
Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Standard of Care: Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.
|
TRE + SOC
n=61 participants at risk
Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Time Restricted Eating + Standard of Care: Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
|
|---|---|---|
|
General disorders
Irritability and Fatigue
|
0.00%
0/61 • 14 weeks
|
1.6%
1/61 • Number of events 1 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place