Fasting Clinical Trial
— E228Official title:
The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
NCT number | NCT03201549 |
Other study ID # | 2017P000053 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2017 |
Est. completion date | June 30, 2023 |
Verified date | August 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Ages 18-60 - BMI 19-25 kg/m2; 19-23 for Asian subjects - Stable weight (variation < 3 kg within 6 months of screening visit) - Ability to give informed consent in English - Use of medically approved form of contraception Exclusion Criteria: - Fasting blood glucose >100 - Hemoglobin A1C% > 6.5% - Fasting triglycerides >150 - Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria - Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure) - Uncontrolled hypertension (BP > 160/100 mmHg on or off antihypertensive medication) intravenous drug use - Recent weight loss (> 3 kg within 6 months of the screening visit) - Gastroparesis - Inflammatory or irritable bowel disease - Malignancy treated with chemotherapy within the past 3 years - Depression or psychosis requiring hospitalization - Renal insufficiency (creatinine clearance < 40 ml/min) - Transaminases > 2x above the normal range - Known liver disease - Pregnancy within 6 months of the screening visit - Lactation - Failure to use medically approved contraceptive methods - History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling) - Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit - History of alcohol abuse within the past 5 years - Fructose intolerance Exclusionary medications: - Oral steroids - Metformin - Weight loss medications including nonprescription supplements |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum FGF21 levels | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03754920 -
Prolonged Fasting With Meditation and Mild Physical Exercise
|
N/A | |
Completed |
NCT05272332 -
Gastric Ultrasound Prior to Extubation
|
||
Completed |
NCT04247464 -
Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients
|
N/A | |
Completed |
NCT01067001 -
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
|
N/A | |
Completed |
NCT00757094 -
Safety and Feasibility of Fasting While Receiving Chemotherapy
|
N/A | |
Completed |
NCT01506713 -
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT04514380 -
Effect of Drinking Carbohydrate-containing Fluids on Gastric Residual Volume in Elderly Patients
|
||
Completed |
NCT05756868 -
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
|
N/A | |
Completed |
NCT05134207 -
The Effect of Oral Carbohydrate Solution on Anxiety and Comfort in Patients Undergoing Hip Arthroplasty
|
N/A | |
Completed |
NCT05031598 -
Long-term Fasting: Multi-system Adaptations in Humans
|
N/A | |
Recruiting |
NCT04501393 -
Recommended Clear Fluid Intake Volume at 2 Hours Prior to Esophagogastroduodenoscopy for Adult Patients
|
N/A | |
Enrolling by invitation |
NCT04027478 -
Can Fasting Decrease the Side Effects of Chemotherapy?
|
N/A | |
Completed |
NCT05219136 -
Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol
|
N/A | |
Recruiting |
NCT04625608 -
Effect of Premedicant Oral Paracetamol on Gastric Volume and pH
|
Phase 4 | |
Not yet recruiting |
NCT02562638 -
Pre-Procedural Fasting in Cardiac Intervention
|
N/A | |
Completed |
NCT01949987 -
Does Oral Intake Decreases Postoperative Pain Score in Children
|
N/A | |
Completed |
NCT01954836 -
Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
|
N/A | |
Completed |
NCT01831700 -
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
|
Phase 1 | |
Completed |
NCT01721187 -
Satiety Effects on the Neural Valuation of Food
|
N/A | |
Completed |
NCT01713647 -
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
|
Phase 1 |