Obesity Clinical Trial
— TRENDNCT number | NCT02837211 |
Other study ID # | IRB00037795 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | May 11, 2018 |
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
TREND is a pilot randomized trial comparing two alternative methods of initiating a low-calorie weight loss diet. The study will compare the traditional diet initiation of abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus a 6 week tapering of energy intake from a baseline level. These two approaches will be compared with respect to their impact on energy regulatory systems of the body, weight loss and other measures, up to a year after diet initiation.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 11, 2018 |
Est. primary completion date | May 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Employee of Wake Forest Baptist Medical Center - BMI 30-40 kg/m2 - Interested in weight loss - <90 min/wk of exercise at baseline - Receives medical care through Wake Forest and has WakeOne account Exclusion Criteria: - Already participating in another diet or weight loss program or research study - History of bariatric surgery - History of eating disorder - History of cancer (other than non-melanomatous skin cancer) - History of thyroid disease - History of severe mental illness - Diagnosis of diabetes - Currently pregnant, breastfeeding or planning pregnancy - Peri or post-menopausal - Food allergies or sensitivities - Vegetarian - Night Shift worker - Planning prolonged travel in next 6-8 months or frequent out of town travel - on any medication that could promote weight loss or weight gain |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ghrelin | Orexogenic hormone | change from baseline at weeks 1, 6, 12, 24, 52 | |
Primary | Leptin | Satiety hormone | change from baseline at weeks 1, 6, 12, 24, 52 | |
Secondary | Glucagon-like peptide-1 (GLP1) | Satiety hormone | change from baseline at weeks 1, 6, 12, 24, 52 | |
Secondary | Body Composition (percent body fat, percent lean mass) | Assessed with DEXA Scan | change from baseline at week 24 and 52 | |
Secondary | Resting Metabolic Rate (RMR) | Assessed with indirect calorimetry | change from baseline at weeks 12, 24, 52 | |
Secondary | Weight (kg) | Change from baseline at weeks 6, 12, 24 and 52 | ||
Secondary | Hunger | Visual-analogue scale, self report | weeks 1, 6, 12, 24, 52 | |
Secondary | Weight-related quality of life (IWQOL-Lite) | Validated survey measure | Change from baseline at weeks 12, 24, and 52 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |