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The Effect of Time-Restricted Eating in Cardiometabolic Health

Primary Purpose

Obesity, Pre-diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
9 hours daily eating window
15 hours daily eating window
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Chrono-nutrition, Adipose tissue, Skeletal muscle, Insulin sensitivity, Diurnal rhythm

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • body mass index 30-39.9 kg/m2
  • fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
  • self-reported habitual eating period > 15 h per day

Exclusion Criteria:

  • shift worker, recent or expected travel crossing time zones
  • fasting >12 h/day more than once a week or vegan
  • shift worker, recent or expected travel crossing time zones
  • fasting >12 h/day more than once a week or vegan
  • > once a week no food intake after 1800 h
  • habitually waking up before 0400 h and sleeping before 2230 h
  • ≥ 150 min per week of structured exercise
  • unstable weight (>5% change the last 2 months)
  • type 2 diabetes or other major chronic disease
  • sleep disorder
  • cancer in last 5 years
  • conditions that render subject unable to complete all testing procedures
  • use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.)
  • smoking and illegal drug use
  • pregnant or lactating
  • menopause
  • individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
  • gastrointestinal or bariatric surgery
  • unable to grant voluntary informed consent or comply with the study instructions
  • individuals who are not yet adults (infants, children, teenagers)
  • prisoners

Sites / Locations

  • University of California, DavisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

TRE group

Control group

Arm Description

Time-restricted eating group

Time-unrestricted eating group

Outcomes

Primary Outcome Measures

Insulin sensitivity
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
24 h glycemic control
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Adipose tissue gene expression
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.

Secondary Outcome Measures

Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
We will evaluate changes in clock gene expression

Full Information

First Posted
July 17, 2020
Last Updated
June 3, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04484987
Brief Title
The Effect of Time-Restricted Eating in Cardiometabolic Health
Official Title
The Effect of Time-Restricted Eating in Cardiometabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
May 20, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-diabetes
Keywords
Chrono-nutrition, Adipose tissue, Skeletal muscle, Insulin sensitivity, Diurnal rhythm

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of two diet interventions: TRE group (eating all their food for the day in 9 hours) or the control group (eating all their food for the day in 15 hours) for 12 weeks. Tests to asses changes in metabolism will be performed before and after the intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRE group
Arm Type
Other
Arm Description
Time-restricted eating group
Arm Title
Control group
Arm Type
Other
Arm Description
Time-unrestricted eating group
Intervention Type
Other
Intervention Name(s)
9 hours daily eating window
Intervention Description
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
Intervention Type
Other
Intervention Name(s)
15 hours daily eating window
Intervention Description
Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
Time Frame
3 months (pre-post intervention)
Title
24 h glycemic control
Description
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
Time Frame
3 months (pre-post intervention)
Title
Adipose tissue gene expression
Description
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
Time Frame
3 months (pre-post intervention)
Secondary Outcome Measure Information:
Title
Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells
Description
We will evaluate changes in clock gene expression
Time Frame
3 months (pre-post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: body mass index 30-39.9 kg/m2 fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4% self-reported habitual eating period > 15 h per day Exclusion Criteria: shift worker, recent or expected travel crossing time zones fasting >12 h/day more than once a week or vegan shift worker, recent or expected travel crossing time zones fasting >12 h/day more than once a week or vegan > once a week no food intake after 1800 h habitually waking up before 0400 h and sleeping before 2230 h ≥ 150 min per week of structured exercise unstable weight (>5% change the last 2 months) type 2 diabetes or other major chronic disease sleep disorder cancer in last 5 years conditions that render subject unable to complete all testing procedures use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.) smoking and illegal drug use pregnant or lactating menopause individuals that have performed procedures involving substantial exposure to radiation in the last 12 months gastrointestinal or bariatric surgery unable to grant voluntary informed consent or comply with the study instructions individuals who are not yet adults (infants, children, teenagers) prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Chondronikola, PhD
Phone
530-754-1977
Email
mchondr@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Romina Sacchi, MS
Phone
5307541766
Email
rsacchi@ucdavis.edu
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616-5398
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romina Sacchi, MS
Phone
530-754-1766
Email
rsacchi@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Maria Chondronikola, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The final dataset will primarily include data collected specifically for the study, but it will also contain some demographic information and historical data regarding family history of diabetes, obesity, and cardiovascular disease. Upon publication of the primary manuscript, we will consider requests to make the study-related data and relevant demographic information (such as ethnicity) available to other investigators. The final dataset, which will not include subject names, will be further stripped of any other unique identifiers and prepared in accordance with all HIPAA regulations prior to release for sharing. No unique subject characteristics will be included in any reports generated by use of the data.
IPD Sharing Time Frame
Upon publication of the study data.
Links:
URL
https://studypages.com/s/a-study-of-time-restricted-eating-on-heart-health-metabolism-306499/
Description
Learn more or sign up for the study here!

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The Effect of Time-Restricted Eating in Cardiometabolic Health

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