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Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04877262
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Claire E. Berryman, Florida State University

Study Description
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Brief Summary:
This 2-period, crossover, controlled-feeding trial will investigate the effects of early time-restricted eating (8am-2pm), compared to a control eating timeframe (8am-8pm), on energy and macronutrient digestibility, the thermic effect of food (TEF), postprandial blood metabolites, 24 h glucose concentrations, glycemic variability, intestinal hydrogen gas production, gastrointestinal transit time, and microbiome composition. This study will also seek to determine factors that may predict intestinal absorption efficiency (i.e., digestibility) including the microbial composition of stool, fasting and postprandial metabolomics, gastrointestinal transit time, thermic effect of food, 24 h glucose concentrations and variability, and hydrogen gas production.

Condition or disease Intervention/treatment Phase
Digestibility Other: weight maintenance diet (WMD) Not Applicable

Detailed Description:

The obesity epidemic is well documented, and despite a complex etiology influenced by genetic, physiological, psychological, social, behavioral, and environmental factors, obesity seems to be the result of energy imbalance, where energy intake exceeds energy expenditure, regardless of the internal and external influences. Studies aiming to quantify and manipulate modulators of energy balance, including gastrointestinal (GI) energy absorption rates (i.e., digestibility), are crucial for reducing the incidence of overweight and obesity and improving overall human health. Despite considerable interindividual variability in the amount of ingested energy that is absorbed (~87-98% of ingested energy) by the gastrointestinal tract, generalized equations are used to calculate individual energy intake requirements, and the factors that contribute to such variability, including meal-timing, are largely unknown.

The proposed study seeks to determine the effects of restricting the eating window to 6-h (early time-restricted eating) as compared to a control eating window of 12 h on energy and macronutrient digestibility, thermic effect of food (TEF), postprandial blood metabolites (triglyceride, insulin, glucose, fructose, galactose, inositol, and sorbitol), 24 h glucose concentrations and glycemic variability, intestinal hydrogen gas production, microbiome composition, and gastrointestinal transit time in response to a controlled, energy balanced diet. In addition, this project will determine whether energy digestibility can be predicted from biological and physiological factors such as gut microbiota composition, gastrointestinal transit time, 24-h glucose concentrations, and postabsorptive and postprandial metabolomic profiles.

Participants will be randomized to early TRE (6-h feeding window, 8am-2pm) or a control eating schedule (12-h feeding window, 8am-8pm) and consume a controlled, energy balance diet (breakfast, lunch, dinner, snacks, and beverages) for 9 consecutive days before crossing over to the other intervention after at least a 3-wk washout for females (to control for hormonal fluctuations) and at least a 2-wk washout for males. Participants will collect stool and urine during each feeding phase. Gross energy content (heat combustion by bomb calorimetry) of the diet, stool, and urine samples will be used to calculate energy digestibility (diet gross energy - stool gross energy) and metabolizable energy. Factors that may mediate and/or predict energy digestibility efficiency, including gastrointestinal microbial composition, transit time, and gas production, fasting and postprandial metabolites, continuous glucose concentrations, and thermogenesis will be assessed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study is a randomized, crossover, controlled feeding study design consisting of two 9-d weight maintenance diet periods separated by at least 3 weeks.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: early time-restricted eating (eTRE)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 6-h window in the morning hours (e.g., 8:00 AM - 2:00 PM)
 Other: weight maintenance diet (WMD)
A diet meeting the participant's weight maintenance energy needs will be provided.
Experimental: control eating schedule (CON)
Participants will be provided a weight-maintenance diet for 9 consecutive days and will consume all meals and snacks in a 12-h window in the morning hours (e.g., 8:00 AM - 8:00 PM)
 Other: weight maintenance diet (WMD)
A diet meeting the participant's weight maintenance energy needs will be provided.


Outcome Measures
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Primary Outcome Measures :
  1. Energy digestibility [ Time Frame: Days 4-9 ]
    Calculated as gross energy of the diet (kcals) - gross energy excreted in stool (kcals)


Secondary Outcome Measures :
  1. Fat digestibility [ Time Frame: Days 4-9 ]
    Calculated as fat content of the diet - fat content excreted in stool

  2. Carbohydrate digestibility [ Time Frame: Days 4-9 ]
    Calculated as carbohydrate content of the diet - carbohydrate content excreted in stool

  3. Protein digestibility [ Time Frame: Days 4-9 ]
    Calculated as protein content of the diet - protein content excreted in stool

  4. Metabolizable energy [ Time Frame: Days 4-9 ]
    Calculated as gross energy of the diet (kcals) - gross energy excreted in urine and stool (kcals)

  5. Metabolizable protein [ Time Frame: Days 4-9 ]
    Calculated as protein content of the diet - protein excreted in urine and stool

  6. Postabsorptive and postprandial plasma metabolites [ Time Frame: Day 6 ]
    Plasma metabolites will be measured using gas chromatography coupled with mass spectrometry in the postabsorptive state and following a standardized meal (1 hour, 2 hours, 3 hours, and 4 hours after meal intake).

  7. Gut microbiome [ Time Frame: Day 6 ]
    Microbiota composition and diversity will be determined using 16S rRNA gene sequencing.

  8. Gastrointestinal transit time [ Time Frame: Day 6 ]
    A gas-sensing capsule will be ingested to measure transit time in the gastrointestinal tract.

  9. Gastrointestinal gas production [ Time Frame: Day 6 ]
    A gas-sensing capsule will be ingested to measure hydrogen, carbon dioxide, and oxygen production in the gastrointestinal tract.

  10. Gastrointestinal temperature [ Time Frame: Day 6 ]
    A gas-sensing capsule will be ingested to measure temperature in the gastrointestinal tract.

  11. 24-h glucose concentrations [ Time Frame: Days 1-8 ]
    A continuous glucose monitor will be used to collect and assess 24-h glucose concentrations.

  12. 24-h glucose variability [ Time Frame: Days 1-8 ]
    A continuous glucose monitor will be used to collect and assess 24-h glucose variability.

  13. Thermic effect of food [ Time Frame: Day 6 ]
    Indirect calorimetry measures will be collected in the resting state and for 4 hours (15-30, 45-60, 75-90, 105-120, 165-180, and 225-240 minutes) following the consumption of a standardized meal.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-45 years old
  • Normal weight or overweight (18.5 to 29.9 kg/m2)
  • Not taking any probiotics for 4 weeks prior to and throughout the entire study
  • Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the study
  • Willing to consume a controlled diet for 9 consecutive days on 2 different occasions (18 days total) and collect all urine and fecal output for 3-5 days during each occasion
  • Pass the blue dye gastrointestinal tracer (given at screening) within 72 hours of administration

Exclusion Criteria:

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders, prior bariatric surgery, malabsorption, or any condition that interferes with metabolism (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
  • Suspected or known strictures, fistulas, or physiological/mechanical gastrointestinal obstruction
  • Present condition of alcoholism, anabolic steroids, or other substance abuse issues
  • Women who are pregnant, lactating, planning to become pregnant, or who have an irregular menstrual cycle in the past 6 months
  • Weight fluctuations ± 5% of body weight in the last 6 months
  • Allergies or intolerance to foods included in the controlled diet
  • Any use of antibiotics, except topical antibiotics, within 3 months of study participation
  • Colonoscopy within 3 months of study participation
  • Use of laxatives, stool softeners, or anti-diarrheal medications more than once a week within 4-weeks of study enrollment
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04877262


Contacts
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Contact: Claire E Berryman, Ph.D. 304-216-1050 cberryman@fsu.edu
Contact: Alan Dawson, M.S. 850-583-6163 madawson@fsu.edu

Locations
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United States, Florida
Florida State University Recruiting
Tallahassee, Florida, United States, 32306
Contact: Claire E Berryman, Ph.D.    304-216-1050    cberryman@fsu.edu   
Contact: Alan Dawson, M.S.    850-583-6163    madawson@fsu.edu   
Sponsors and Collaborators
Florida State University
Investigators
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Principal Investigator: Claire E Berryman, Ph.D. Florida State University
More Information
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Responsible Party: Claire E. Berryman, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT04877262    
Other Study ID Numbers: STUDY00001564
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: November 2021
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 Claire E. Berryman, Florida State University:
stool energy loss
digestibility
intestinal absorption
overweight
 microbiome
metabolomics
energy balance