Intermittent Fasting as a Means to Lose Fluid Overload and Weight in Complicated Obesity

NCT04193995 | Unknown

• 1 other identifier: 0460-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the feasibility of intermittent fasting (36h, twice a week, unlimited salt and calorie-free fluid consumption), over three months, on body weight and composition in complicated obesity in whom age and medical complexity exclude the possibility of bariatric surgery.

Conditions

Intermittent Fasting; Obesity, Morbid; Comorbidities and Coexisting Conditions; Weight Loss; Fluid Retention

Outcome Measures

Primary Outcomes (4)

• Weight change

  % weight change

  from baseline to 12 weeks

• Fluid change

  % change in fluids (extracellular water as proxies for edema)

  from baseline to 12 weeks

• Fat percentage

  % change in fat percentage

  from baseline to 12 weeks

• Muscle mass

  % change in muscle mass

  from baseline to 12 weeks

Secondary Outcomes (9)

• Blood tests changes - glycemic control

  from baseline to 12 weeks

• Blood tests changes - glycemic control

  from baseline to 12 weeks

• Blood tests changes- lipid panel change

  from baseline to 12 weeks

• Urine tests changes

  from baseline to 12 weeks

• Home sleep laboratory using watch PAT FDA-approved portable diagnostic device

  from baseline to 12 weeks

Study Arms (1)

Intermittent fasting

EXPERIMENTAL

There are two 36h fasting periods (FP) every week, over a 12week period. Free access to water is allowed; two cups of tea or coffee are also allowed. Each 36h FP begins after the last meal, which is consumed no later than 2000h on the preceding nights. Fasting days are Sunday and Wednesday and fasting is terminated at 0800 on Monday and Thursday.

Behavioral: Intermittent fasting

Interventions

Intermittent fasting BEHAVIORAL

There are two 36h fasting periods (FP) every week, over a 12week period. Free access to water is allowed; two cups of tea or coffee are also allowed. Each 36h FP begins after the last meal, which is consumed no later than 2000h on the preceding nights. Fasting days are Sunday and Wednesday, and fasting is terminated at 0800 on Monday and Thursday. Medications may be adjusted as needed during these visits, and this is reconsidered and may be further adjusted after the receipt of the blood tests results later during the day. Adjustments based on lab results are discussed with the patients during the clinic visit or later on the same day. Also, dietary needs are addressed by the physician and /or the dietician, during the clinic visit. As of week 3 through week 12, clinic visit is reduced to once a week, on Thursdays.

Intermittent fasting

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with complicated obesity grade 2 or higher (Body Mass Index \[BMI\]\>35kg/m2), i.e., obesity associated with renal failure with eGFR\<60cc/min or heart failure with preserved ejection fraction (EF) (≥50%) and clinical evidence of fluid retention evidenced by the use of loop diuretic, or the presence of peripheral edema; or treatment in congestive heart failure clinics or history of admission to the hospital for heart failure during the past 3 years; OR • b. Subjects with complicated obesity, grade 2 or higher (BMI\>35 kg/m2) \[with renal failure as defined above-delete this requirement\] and at least one of the following comorbidities: 1) Uncontrolled hypertension despite the use of at least 3 drugs administered at their maximal or close to maximal dose 2) Severe sleep apnea (based on a sleep lab report) 3) Pulmonary hypertension 4) Coronary heart disease 5) Type 2 diabetes mellitus 6) History of stroke (\> 3 months prior to the recruitment to the trial) 2) Subjects who failed to lose weight on standard treatment, refuse standard medical treatment or are judged as unable to tolerate/unsuitable to receive standard medical treatment to lower body weight and in whom bariatric surgery is deemed unacceptable due to excessive surgical risk by the referring physician and/ or the PI and / or the patient and fulfill the following criteria
• Wish to fast 36 hours, twice a week, over three months
• Committed to attend the clinic at least once a week and perform blood tests every 2-14 days, as detailed in the protocol.
• Are well trained in-home glucose monitoring and are willing to monitor glucose levels during the fasting days.
• Are well trained in-home monitoring of blood pressure and are willing to measure blood pressure twice a day during the fasting days.
• Own and control a dependable means of 24/7 communication device, eg, cell phone, and are committed to avail this route of communication to the study staff.

You may not qualify if:

• Severe renal failure (eGFR\<20cc/min)
• Liver disease other than non-alcoholic fatty liver disease or cardiac cirrhosis or any liver disease with aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase levels\>3 times of the upper limit of the normal range, albumin\< 3.5 gr% or direct bilirubin\>1.2 mg%.
• Cognitive impairment assessed by a Mini-Mental State Exam (MMSE) score \< 24
• Living in a single household (caretaker is allowed)
• Age less than 18 or \>85 years
• Pregnancy or intention to conceive or female at the reproductive age not using birth control means.
• History of documented hypoglycemia during the past year despite attempted adjustment of treatment.
• Unintended weight loss \> 2kg over the past 2 months.
• The initiation, within the study period of any one of the following medications, including topiramate, lyxumia, byetta, bydureon, belviq, Xenical, victoza, saxenda, trulicity, semaglutide or any other glucagon-like peptide-1 (GLP-1) analog. However, subjects already treated with these agents before the initiation of the trial may be included provided that the medication has been started at least 4 months prior to the beginning of the study and that weight loss during the 2 months preceding the trial did not exceed 2 kgs.
• A subject who must use drugs whose use is not recommended on an empty stomach and in whom this qualification appears, in the investigator's opinion more critical than the potential chance to lose weight and excrete excess bodily fluids.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Institute of Endocrinology, Metabolism and Hypertension

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Naftali Stern, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naftali Stern, MD

CONTACT

+972-3-6973732; naftalis@tlvmc.gov.il

Yael Sofer, MD PhD

CONTACT

+972-52-7360462; yaelso@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: December 11, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: June 2, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)