Status:
COMPLETED
Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults
Lead Sponsor:
Florida State University
Conditions:
Digestibility
Eligibility:
All Genders
20-45 years
Phase:
NA
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...
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 resu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04877262
Start Date
December 1 2021
End Date
June 10 2022
Last Update
June 23 2022
Active Locations (1)
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1
Florida State University
Tallahassee, Florida, United States, 32306