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

NCT03809299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-02-13

No results posted yet for this study

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

Interventions

OTHER

Ad libitum meal timing

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

OTHER

Twice a day meals

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Jill Crandall, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809299 on ClinicalTrials.gov