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

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT04877262

Collaborator

(none)

Enrollment

Location

Arms

6.3

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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

Study Type:

Interventional

Actual Enrollment :

17 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.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 :

Dec 1, 2021

Actual Primary Completion Date :

Jun 10, 2022

Actual Study Completion Date :

Jun 10, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

Energy digestibility [Days 4-9]
Calculated as gross energy of the diet (kcals) - gross energy excreted in stool (kcals)

Secondary Outcome Measures

Fat digestibility [Days 4-9]
Calculated as fat content of the diet - fat content excreted in stool
Carbohydrate digestibility [Days 4-9]
Calculated as carbohydrate content of the diet - carbohydrate content excreted in stool
Protein digestibility [Days 4-9]
Calculated as protein content of the diet - protein content excreted in stool
Metabolizable energy [Days 4-9]
Calculated as gross energy of the diet (kcals) - gross energy excreted in urine and stool (kcals)
Metabolizable protein [Days 4-9]
Calculated as protein content of the diet - protein excreted in urine and stool
Postabsorptive and postprandial plasma metabolites [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).
Gut microbiome [Day 6]
Microbiota composition and diversity will be determined using 16S rRNA gene sequencing.
Gastrointestinal transit time [Day 6]
A gas-sensing capsule will be ingested to measure transit time in the gastrointestinal tract.
Gastrointestinal gas production [Day 6]
A gas-sensing capsule will be ingested to measure hydrogen, carbon dioxide, and oxygen production in the gastrointestinal tract.
Gastrointestinal temperature [Day 6]
A gas-sensing capsule will be ingested to measure temperature in the gastrointestinal tract.
24-h glucose concentrations [Days 1-8]
A continuous glucose monitor will be used to collect and assess 24-h glucose concentrations.
24-h glucose variability [Days 1-8]
A continuous glucose monitor will be used to collect and assess 24-h glucose variability.
Thermic effect of food [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

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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