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Trial record 81 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03809299
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jill Crandall, Albert Einstein College of Medicine

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

Condition or disease Intervention/treatment Phase
PreDiabetes Other: Ad libitum meal timing Other: Twice a day meals Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 2-A-Day Study: Twice a Day Meals Study.
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Ad libitum meal timing first
This arm will receive the ad libitum meal timing intervention first, followed by the twice a day feeding intervention.
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.

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




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 5 weeks ]
    insulin sensitivity as measured by the Matsuda Index


Secondary Outcome Measures :
  1. Glucose tolerance [ Time Frame: 5 weeks ]
    Glucose level after oral glucose tolerance test as measured by glucose area under the curve.

  2. Body Composition [ Time Frame: 5 weeks ]
    Fat mass as estimated by bioimpedance analysis

  3. Energy expenditure [ Time Frame: 5 weeks ]
    Resting energy expenditure as estimated by indirect calorimetry

  4. Autophagy level [ Time Frame: 1 week ]
    Expression of levels of autophagosome marker LC3 by immunoblotting



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809299


Contacts
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Contact: Jill Crandall 7184303765 jill.crandall@einstein.yu.edu
Contact: Erika Brutsaert 7188397961 erika.brutsaert@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine of Yeshiva University Recruiting
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jill Crandall, MD Albert Einstein College of Medicine

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Responsible Party: Jill Crandall, Professor, Dept of Medicine (Endocrinology), Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03809299     History of Changes
Other Study ID Numbers: 2018-9671
5P30DK020541 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Crandall, Albert Einstein College of Medicine:
Caloric restriction
Fasting
intermittent fasting
isocaloric ad lib meal timing
Twice-a-day feeding
insulin
glucose metabolism
normoglycemia
hyperglycemia
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases