Fasting Clinical Trial
Official title:
The Effect of Modulating Hepatic Glycogen Content on Hepatic Fat Oxidation
Verified date | October 2020 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Excessive fat in the liver is associated with impairments in metabolic health. Low levels of
DNL and high levels of hepatic fat oxidation are considered to be protective.
A decrease in glycogen stores has been causally linked to improved whole body fat oxidation.
Also on an organ level, it is suggested that hepatic fat oxidation is stimulated by low
hepatic glycogen stores. Next to hepatic fat oxidation, DNL may be influenced by hepatic
glycogen stores. Some studies have shown that prolongation of fasting time lowers hepatic
glycogen content. It is therefore hypothesized that prolonging fasting time will lower
glycogen content and thereby increases fat oxidation and decreases DNL in the liver. To this
end, hepatic fat oxidation (plasma marker beta-hydroxybutyrate), de novo lipogenesis, hepatic
glycogen content and intrahepatic fat content, will be measured upon a short overnight fast
and an extended overnight fast in 13 overweight/obese subjects with hepatic steatosis.
Status | Completed |
Enrollment | 11 |
Est. completion date | January 13, 2020 |
Est. primary completion date | January 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Caucasian (people will be excluded when having a =50% racial African/Asian background) - Male or postmenopausal female - Aged 45-75 years at start of the study - Body mass index (BMI) 27 - 38 kg/m2 - Stable dietary habits (no weight loss or gain >3kg in the past 3 months) - Sedentary lifestyle (not more than 2 hours of sports per week) - Liver fat =5% as determined by 1H-MRS Exclusion Criteria: - Type 2 diabetes - Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other) - Contra-indication for MRI (which can be found in appendix II) - Alcohol consumption of >2 servings per day - Regular smoking (>5 cigarettes per day) - No use of medication interfering with investigated study parameters (as determined by responsible physician) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Unilever R&D |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hepatic glycogen content | Measured with 13C-MRS | 1 hour | |
Other | Intrahepatic fat accumulation and composition | Measured with 1H-MRS | 20 minutes | |
Other | Substrate oxidation | measured with indirect calorimetry | 30 minutes | |
Other | Plasma metabolites related to energy metabolism | measured in plasma samples | 5 hours | |
Other | Body composition | fat mass/fat free mass measured with BodPod | 5 minutes | |
Primary | Hepatic fat oxidation | measured as plasma BHB levels | 5 hours | |
Secondary | De novo lipogenesis (DNL) | measured as percentage of palmitate in VLDL-TG originating from DNL | 20 hours |
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 |
NCT01954836 -
Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
|
N/A | |
Completed |
NCT01949987 -
Does Oral Intake Decreases Postoperative Pain Score in Children
|
N/A | |
Completed |
NCT01721187 -
Satiety Effects on the Neural Valuation of Food
|
N/A | |
Completed |
NCT01746719 -
Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition
|
Phase 1 | |
Completed |
NCT01831700 -
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
|
Phase 1 |