Excessive Diet Restriction Clinical Trial
Official title:
The Proposed Study Entails a Follow-up of All the Completers for 2 Years With Visits Timed 3, 6, 12 and 24 Months After Completion of the 2-year CALERIE II Intervention.
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
You will not be assigned to any particular group during the Follow-Up Study. In the
Follow-Up study there is no diet intervention. You will not be asked to follow a
calorie-restricted diet or any other diet.
Month 3 and Month 6 (Outpatient Visits)following procedures performed:
- Blood pressure, heart rate, temperature, Weight & Waist Measurement
- Medication and medical history
- Blood draw (approximately ½ cup)
- DEXA and QuickScan
- Psychological assessment questionnaires reviewed for completeness
- Body Acceptability Morph Test (BAM)
- Review of 7-day food diary
Month 12 and Month 24 (Outpatient Visits) procedures performed:
- Collection of 4 urine samples
- Dosing with doubly labeled water (DLW)
- DEXA and QuickScan
- Eat breakfast and lunch
- Receive 7-day food diary
- Psychological assessment questionnaires
- Body Acceptability Morph Test (BAM)
Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures
performed:
- Collection of 2 urine samples
- Blood pressure, heart rate, temperature, Weight & Waist Measurement
- Blood draw (approximately ½ cup)
- Medication and medical history
- Review of 7-day food diary
- Metabolic Chamber
- Resting Metabolic Rate (RMR)
;
Observational Model: Case-Only
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02673515 -
The Impact of Intermittent Fasting on Human Metabolism and Cell Autophagy
|
N/A |