Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610162
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Thermogenenic Responses to Fasting and Overfeeding in Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Thermogenic Responses to Fasting and Overfeeding in Women a Potential Mechanism Contributing to Postmenopausal Weight Gain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study plans to learn more about why menopause increases the risk of weight gain During and after menopause women are prone to increased weight gain The weight gained is primarily body fat particularly visceral or abdominal body fat The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen This study plans to compare how the metabolism of premenopausal and postmenopausal women responds to changes in energy intake The investigators will compare the changes in energy expenditure that occur during a period of acute fasting 24 hours and a period of consuming excess calories overfeeding
Detailed Description:
This cross-sectional study will compare fasting and overfeeding effects on 24-hour EE and its components in pre- and postmenopausal women The investigators will study participants under three conditions in the room calorimeter 1 eucaloric feeding energy intake EE 2 acute 24-hour fasting and 3 acute 24-hour overfeeding of a low-protein diet ie 200 of energy requirements Participants will complete the eucaloric study and then complete the overfeeding and fasting studies in random order For 3 days before each condition the investigators will provide participants with an outpatient diet designed to meet free-living energy requirements energy intake 15 x REE and stabilize macronutrient intake 15 protein 30 fat 55 carbohydrate There will be a 1-4-week washout between conditions Studies in premenopausal women will be performed during the mid-luteal phase ie days 16-24 when both E2 and progesterone are elevated and thus when the potential hormonal effects are maximal
Pre-study assessments - Once enrolled participants will complete a pre-study assessment visit in the Clinical and Translational Research Center CTRC Outpatient Clinic and the following assessments will be performed
1 Resting energy expenditure REE - will be measured by indirect calorimetry using a metabolic cart coupled with a canopy system Parvo Medics TrueOne and used to estimate energy requirements during the eucaloric condition REE in premenopausal women will be measured in the luteal phase Participants will arrive after an overnight fast ampampampampgt10 hours between 7 and 9 AM They will rest while remaining awake for 30 minutes in a temperature-controlled room 70⁰ F Oxygen uptake VO2 and carbon dioxide production VCO2 will be measured for 20 minutes and averaged over the final 15 minutes
2 Body composition - Body composition will be measured using dual X-ray absorptiometry DXA Hologic Discovery Waltham MA
3 Visceral adipose tissue VAT volume - VAT volume and subcutaneous fat area SFA will be measured using computed tomography CT An instrument dedicated to research activity will be used for all scans Philips Gemini 64TF Axial CT images will be obtained through the center of the L2-L3 and L4-L5 inter-vertebral disc spaces
Study Procedures Once the pre-screening assessments are completed participants will be studied under three conditions in the room calorimeter
Room calorimeter - 24-hour EE and substrate oxidation will be measured using whole-room indirect calorimetryFor three days before each calorimeter study participants will be instructed to refrain from exercise and provided with all food to stabilize energy and macronutrient intake The energy content of the diet will be REE x 15 30 fat 55 carbohydrate 15 protein Participants will arrive at 0700h after an overnight fast on the study day An IV catheter will be inserted in an antecubital vein Fasting blood samples will be obtained before breakfast and at the end of the 24-hour study and analyzed for leptin FGF21 and thyroid hormones TSH total T3 free T4 The investigators will also measure sex steroids E2 progesterone in premenopausal women to confirm that participants are studied in the luteal phase
Participants will enter the calorimeter at 0800 exit at 0700 the following day and be instructed to engage in primary sedentary behaviors eg reading watching TV using the computer During the eucaloric and overfeeding studies meals will be provided at 0900 1300 and 1800 and a light snack will be provided at 2000 Participants will be instructed to turn out the lights and prepare for bed no later than 2300 Participants will record their time in bed during the first visit and be instructed to prepare for bed during the subsequent two visits The CTRC nursing staff will confirm bedtimes Participants will be awoken at 0600 and a 30-minute measurement of REE will be obtained
Participants will be monitored during this time to ensure that they remain awake and motionless
The energy content of the diet during the calorimeter study will vary according to the study condition
During the eucaloric study visit the energy content of the diet will be 13 x REE 30 fat 55 carbohydrate and 15 protein at each meal Breakfast will account for 25 and lunch and dinner 30-35 of total energy needs During the overfeeding study macronutrient intake will be 3 protein 51 carbohydrate and 46 fat During the fasting study visit participants will be permitted to consume non-caloric beverages ie water non-caloric and non-caffeinated soft drinks caffeine-free tea or decaffeinated coffee but refrain from consuming any caloric food or beverages Upon exiting the calorimeter participants will be provided a meal from the University of Colorado Hospital Patient Kitchen
Blood samples will also be obtained 30 minutes after each meal and snack during the eucaloric and overfeeding conditions blood samples will be obtained at the same time during the fasting study Blood samples during the calorimeter studies are obtained by asking participants to extend an arm through an airlock in the side of the calorimeter The investigators will store these samples for potential future analysis eg proteomics metabolomics and hunger and satiety hormones see Future Directions During each condition a 24-hour urine sample will be collected and analyzed for urine nitrogen and urea nitrogen which are needed to perform substrate oxidation calculations as well as for 24-hour urinary catecholamines
Pre-study assessments - Once enrolled participants will complete a pre-study assessment visit in the Clinical and Translational Research Center CTRC Outpatient Clinic and the following assessments will be performed
1 Resting energy expenditure REE - will be measured by indirect calorimetry using a metabolic cart coupled with a canopy system Parvo Medics TrueOne and used to estimate energy requirements during the eucaloric condition REE in premenopausal women will be measured in the luteal phase Participants will arrive after an overnight fast ampampampampgt10 hours between 7 and 9 AM They will rest while remaining awake for 30 minutes in a temperature-controlled room 70⁰ F Oxygen uptake VO2 and carbon dioxide production VCO2 will be measured for 20 minutes and averaged over the final 15 minutes
2 Body composition - Body composition will be measured using dual X-ray absorptiometry DXA Hologic Discovery Waltham MA
3 Visceral adipose tissue VAT volume - VAT volume and subcutaneous fat area SFA will be measured using computed tomography CT An instrument dedicated to research activity will be used for all scans Philips Gemini 64TF Axial CT images will be obtained through the center of the L2-L3 and L4-L5 inter-vertebral disc spaces
Study Procedures Once the pre-screening assessments are completed participants will be studied under three conditions in the room calorimeter
Room calorimeter - 24-hour EE and substrate oxidation will be measured using whole-room indirect calorimetryFor three days before each calorimeter study participants will be instructed to refrain from exercise and provided with all food to stabilize energy and macronutrient intake The energy content of the diet will be REE x 15 30 fat 55 carbohydrate 15 protein Participants will arrive at 0700h after an overnight fast on the study day An IV catheter will be inserted in an antecubital vein Fasting blood samples will be obtained before breakfast and at the end of the 24-hour study and analyzed for leptin FGF21 and thyroid hormones TSH total T3 free T4 The investigators will also measure sex steroids E2 progesterone in premenopausal women to confirm that participants are studied in the luteal phase
Participants will enter the calorimeter at 0800 exit at 0700 the following day and be instructed to engage in primary sedentary behaviors eg reading watching TV using the computer During the eucaloric and overfeeding studies meals will be provided at 0900 1300 and 1800 and a light snack will be provided at 2000 Participants will be instructed to turn out the lights and prepare for bed no later than 2300 Participants will record their time in bed during the first visit and be instructed to prepare for bed during the subsequent two visits The CTRC nursing staff will confirm bedtimes Participants will be awoken at 0600 and a 30-minute measurement of REE will be obtained
Participants will be monitored during this time to ensure that they remain awake and motionless
The energy content of the diet during the calorimeter study will vary according to the study condition
During the eucaloric study visit the energy content of the diet will be 13 x REE 30 fat 55 carbohydrate and 15 protein at each meal Breakfast will account for 25 and lunch and dinner 30-35 of total energy needs During the overfeeding study macronutrient intake will be 3 protein 51 carbohydrate and 46 fat During the fasting study visit participants will be permitted to consume non-caloric beverages ie water non-caloric and non-caffeinated soft drinks caffeine-free tea or decaffeinated coffee but refrain from consuming any caloric food or beverages Upon exiting the calorimeter participants will be provided a meal from the University of Colorado Hospital Patient Kitchen
Blood samples will also be obtained 30 minutes after each meal and snack during the eucaloric and overfeeding conditions blood samples will be obtained at the same time during the fasting study Blood samples during the calorimeter studies are obtained by asking participants to extend an arm through an airlock in the side of the calorimeter The investigators will store these samples for potential future analysis eg proteomics metabolomics and hunger and satiety hormones see Future Directions During each condition a 24-hour urine sample will be collected and analyzed for urine nitrogen and urea nitrogen which are needed to perform substrate oxidation calculations as well as for 24-hour urinary catecholamines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None