MEAL TIMING Study: Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

PreDiabetes Clinical Trial

Official title:

Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504683
• Other study ID #: IRB-300001180
• Secondary ID: R01DK118236
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Courtney M. Peterson, Ph.D.
• Phone: 205-934-0122
• Email: cpeterso[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted eating; TRE) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRE also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRE can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRE depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRE' (eat between ~8 am-3 pm), (2) 'Mid-day TRE' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 8 weeks. All food will be provided and matched between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 30-70 years old
• Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl with HbA1c >= 5.1%
• Fasting insulin less than 100.0 mU/l and, if HbA1c <5.7%, must also have fasting insulin >= 8.0 mU/l
• BMI between 30-60 kg/m^2
• Wake up at a regular time between 5-8 am

Exclusion Criteria:

• Been diagnosed with diabetes or on diabetes medication or any medication known to affect glucose or 24-hour rhythms in blood pressure
• On weight loss medication
• Change in the dosage of a chronic medication within the past 2 months
• Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)
• Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones
• Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity
• Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years
• Pregnant or breastfeeding
• Diagnosed psychiatric conditions
• Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night
• Major change in health or medical history in the past 3 months
• Currently perform overnight shift work
• Regularly eat within a <10.5-hour period each day
• Lost or gained more than 4% of weight in the past 2 months
• Traveled more than 2 time zones away in the 2 months prior to enrolling in this study
• Will travel outside the Central time zone in the 2 weeks prior to testing
• Will travel more than 1 time zone away during this study
• Behavioral factors or other circumstances that may make it difficult for you to follow the study requirements

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Early TRE
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
• Mid-day TRE
Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
• Control Schedule
Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	Percent adherence to assigned meal timing group	8 weeks
Other	Body weight	Change in body weight (kg) as measured by scale weight	8 weeks
Other	Appetite across the day	Subjective appetite as measured by Visual Analog Scales across the waking day	8 weeks
Other	Appetite	Subjective appetite as measured by retrospective Visual Analog Scales (VAS)	8 weeks
Other	Appetite and Cravings	Subjective appetite and cravings as measured by Likert scales	8 weeks
Other	Eating Self-Efficacy	Eating self-efficacy as measured by the Weight Loss Efficacy Lifestyle Questionnaire (WEL-8)	8 weeks
Other	Sleepiness	Sleepiness as measured by the Karolinska Sleepiness Scale (KSS) across the waking day	8 weeks
Other	Current and Preferred Eating Times	Current and preferred eating times as measured by a custom designed chrononutrition questionnaire	8 weeks
Other	Mood	Mood as measured by the Visual Analog Mood Scales (VAMS)	8 weeks
Other	Positive Affect	Positive Affect as measured by the PROMIS Positive Affect Short Form (PASF)	8 weeks
Other	Stress	Stress as measured by the Perceived Stress Scale (PSS)	8 weeks
Other	Anxiety	Anxiety as measured by the General Anxiety Disorder-7 (GAD-7)	8 weeks
Other	Depression	Depression as measured by the Patient Health Questionnaire-9 (PHQ-9)	8 weeks
Other	Sleep Quality	Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)	8 weeks
Other	Sleep Timing, Duration, and Chronotype	Sleep timing and duration as measured by the Munich Chronotype Questionnaire (MCTQ)	8 weeks
Other	Chronotype	Chronotype as assessed by the reduced Morningness-Eveningness Questionnaire (rMEQ)	8 weeks
Other	GPAQ	Physical activity as assessed by the General Physical Activity Questionnaire (GPAQ)	8 weeks
Other	Exit Interview	Qualitative data on experiences with the eating schedules and barriers, facilitators, and satisfaction factors	8 weeks
Other	Sleep timing outcomes	Sleep duration, sleep timing, sleep latency, and wake after sleep onset as measured by actigraphy watch. (These all have units of time)	8 weeks
Other	Sleep efficiency and disruption	Sleep efficiency (%) and awakenings (no.), as measured by actigraphy watch. (These all have dimensionless units.)	8 weeks
Other	Other sleep outcomes	Sleep Fragmentation Index (awakenings per time), as measured by actigraphy watch	8 weeks
Primary	Mean 24-hour glucose levels	Mean 24-hour glucose levels (mg/dl)	8 weeks
Primary	Mean 24-hour insulin levels	Mean 24-hour insulin levels (mU/l)	8 weeks
Primary	Mean 24-hour C-peptide levels	Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.	8 weeks
Primary	Insulin sensitivity	Mean value of insulin sensitivity (dl/kg/min/µU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model	8 weeks
Primary	Beta-cell responsivity index (a measure of beta-cell function)	Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model	8 weeks
Primary	Glucose AUCs	Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period	8 weeks
Primary	Insulin AUC	Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period	8 weeks
Primary	C-peptide AUC	C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period	8 weeks
Primary	Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values	mg/dl	8 weeks
Secondary	Mean 24-hour systolic and diastolic blood pressure	mmHg	8 weeks
Secondary	Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure	mmHg	8 weeks
Secondary	Percentage of individuals with non-dipping blood pressure phenotypes		8 weeks
Secondary	Heart Rate	beats per minute	8 weeks
Secondary	Lipids	Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)	8 weeks
Secondary	High Sensitivity C-Reactive Protein (hs-CRP)	mg/l	8 weeks
Secondary	Cortisol	µg/dl	8 weeks
Secondary	8-isoprostane	pg/ml	8 weeks