2-A-Day Study: Twice a Day Meals Study.

NCT03809299 | Completed DMC

• 2 other identifiers: 2018-96715P30DK020541
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Caloric restriction increases lifespan and/or healthspan across multiple species. However implementation of long-term CR in humans is problematic and unacceptable to many individuals. As a result, intermittent fasting models have been developed to improve adherence. Such models have been shown to improve blood pressure, insulin sensitivity, decrease hepatic fat content and body weight. Investigators established an isocaloric twice-a-day (ITAD) feeding plan in mice, wherein test mice were acclimatized to consume over two hour periods (8-10am and 5-7pm), the same amount of food as ad-libitum mice. This intervention prevented obesity and age-associated type 2 diabetes via system-wide activation of autophagy. The investigators will perform further studies of the same feeding model in humans in a randomized crossover design. The objective is to test the hypothesis that restricting eating periods to twice a day (TAD), when compared to isocaloric ad lib meal timing (ALMT), will have beneficial effects on glucose metabolism, body composition, energy expenditure and autophagy in human subjects at risk for diabetes

Conditions

PreDiabetes

Keywords

Caloric restriction; Fasting; intermittent fasting; isocaloric ad lib meal timing; Twice-a-day feeding; insulin; glucose metabolism; normoglycemia; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  insulin sensitivity as measured by the Matsuda Index

  5 weeks

Secondary Outcomes (4)

• Glucose tolerance

  5 weeks

• Body Composition

  5 weeks

• Energy expenditure

  5 weeks

• Autophagy level

  1 week

Study Arms (2)

Ad libitum meal timing first

OTHER

This arm will receive the ad libitum meal timing intervention first, followed by the twice a day feeding intervention.

Other: Ad libitum meal timing; Other: Twice a day meals

Twice a day meals first

OTHER

This arm will receive the twice a day feeding intervention first, followed by the ad libitum meal timing intervention.

Other: Ad libitum meal timing; Other: Twice a day meals

Interventions

Ad libitum meal timing OTHER

Research participants will eat meals provided by the study throughout the day, ad libitum

Ad libitum meal timing first; Twice a day meals first

Twice a day meals OTHER

Research participants will eat meals provided by the study at two intervals during the day, and fast in between.

Ad libitum meal timing first; Twice a day meals first

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Prediabetic State; Fasting; Intermittent Fasting; Insulin Resistance; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Hyperinsulinism

Study Officials

• Jill Crandall, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 18, 2019
• Study Start: June 20, 2019
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)