Effect of Dietary Patterns on Energy Balance Control and Circadian Rhythms

Dietary Habits Clinical Trial

Official title:

Effect of Dietary Patterns on Energy Balance Control and Circadian Rhythms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05800990
• Other study ID #: 2022A006894
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: November 2023
• Source: Brigham and Women's Hospital
• Contact: Jingyi Qian, PhD
• Phone: 6175257423
• Email: jqian[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure.

Participants will:

complete 2 field-based dietary interventions be provided with standard meals record daily food intakes in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, stool and rectal swab samples

Description:

Obesity is an ongoing epidemic and a serious public health problem. Recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. Particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. The study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. This study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 yr old

• BMI 18.5-29.9

• No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)

Exclusion Criteria:

• Currently smoking/vaping or 5 or more years of smoking/vaping

• History of drug or alcohol dependency

• History of psychiatric illness or disorder

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Behavioral:
• dietary intervention
Research participants will be assigned to two dietary conditions.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diurnal variations of postprandial ghrelin responses	Postprandial circulating ghrelin will be measured at test meals on Test Day	Days 17
Other	Diurnal profile of leptin	Circulating leptin will be measured hourly on Test Day	Days 17
Other	Diurnal profile of subjective hunger ratings	Hourly subjective hunger will be measured by Visual Analog on Test Day	Day 17
Other	Circadian amplitude of resting energy expenditure	Hourly resting energy expenditure will be measured by indirect calorimetry under the Constant Routine condition	Days 18-19
Other	Diurnal profile of resting energy expenditure	Resting energy expenditure will be measured at 1-2 hours interval by indirect calorimetry on Test Day	Day 17
Other	Diurnal profile of respiratory exchange ratio	Respiratory exchange ratio will be measured at 1-2 hours interval by indirect calorimetry on Test Day	Day 17
Other	Circadian amplitude and phase of respiratory exchange ratio	Hourly respiratory exchange ratio will be measured by indirect calorimetry under the Constant Routine condition	Days 18-19
Other	Circadian phase and amplitude of glucose rhythm	Hourly circulating glucose will be measured under the Constant Routine condition	Days 18-19
Other	Circadian phase and amplitude of insulin rhythm	Hourly circulating insulin will be measured under the Constant Routine condition	Days 18-19
Other	Circadian phase and amplitude of cortisol rhythm	Hourly circulating cortisol will be measured under the Constant Routine condition	Days 18-19
Other	Circadian phase and amplitude of core body temperature rhythm	Core body temperature will be measured continuously under the Constant Routine condition	Days 18-19
Other	Diurnal profile of lipids	Hourly circulating lipids will be measured on Test Day	Day 17
Other	Circadian phase and amplitude of lipids	Hourly circulating lipids will be measured under Constant Routine condition	Days 18-19
Primary	Circadian phase of melatonin rhythm	Hourly plasma melatonin will be measured under the Constant Routine condition	Days 18-19
Primary	Percentage of daily caloric intake in the biological evening	Percentage of caloric intake within the 4 hours before bedtime will be derived from real-time record of food and beverage intake during the intervention period	Days 7-14
Secondary	Circadian amplitude of melatonin rhythm	Hourly circulating melatonin will be measured under the Constant Routine condition	Days 18-19
Secondary	Circadian amplitude of subjective hunger rhythms	Hourly subjective hunger will be measured by Visual Analog under the Constant Routine condition	Days 18-19
Secondary	Circadian phase of resting energy expenditure	Hourly energy expenditure will be measured by indirect calorimetry under the Constant Routine condition	Days 18-19