2-A-Day Study: Twice a Day Meals Study.
PreDiabetes
About this trial
This is an interventional treatment trial for PreDiabetes focused on measuring Caloric restriction, Fasting, intermittent fasting, isocaloric ad lib meal timing, Twice-a-day feeding, insulin, glucose metabolism, normoglycemia, hyperglycemia
Eligibility Criteria
Inclusion Criteria:
● Men, age 30-70 years. In this preliminary study, recruitment is limited to men because data from the relevant animal studies showed marked sexual dimorphism, with more pronounced metabolic effects in males. Future studies will include both males and females.
IFG or IGT based on 75g OGTT (fasting plasma glucose 100 -125 mg/dl and/or 2-hr glucose between 140 - 199 mg/dl); Or diabetes (FPG > 126 mg/dl or 2 hr glucose > 200 mg/dl) not on treatment and with HbA1c < 6.8% can also be enrolled.
- BMI 25-35 kg/m2
Exclusion Criteria:
- Type 2 diabetes with A1C ≥6.8% or on drug treatment; Type 1 diabetes
- Treatment with drugs known to influence glucose metabolism (diabetes medications, systemic glucocorticoids, niacin > 500 mg/day)
- Current smoking, alcohol or drug abuse
- Vigorous habitual physical activity (e.g., marathon runner, heavy weights trainers)
- Subjects with symptomatic gastrointestinal disorders or intolerance (e.g., food allergies, lactose intolerance, gluten sensitivity, etc.) or other conditions requiring special diet or meal timing.
- Subjects with serious chronic illness: severe (activity limiting) COPD, NYHA class 3 or 4 heart failure, kidney disease (eGFR<45ml/min), liver enzyme abnormalities (ALT > 2 times ULN), stroke, MI or ACS within last 6 months, cancer or HIV disease under treatment.
- Any other disease/condition that the investigator believes may interfere with participation in the study (e.g., eating disorder).
- Unstable weight conditions: gain or loss of > 5 pounds or 2.5% body weight in past 3 months.
Sites / Locations
- Albert Einstein College of Medicine of Yeshiva UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Ad libitum meal timing first
Twice a day meals first
This arm will receive the ad libitum meal timing intervention first, followed by the twice a day feeding intervention.
This arm will receive the twice a day feeding intervention first, followed by the ad libitum meal timing intervention.