Bariatric Surgery CandidateNCT06850493
Ketogenic Diet Prior to Bariatric Surgery
A study testing VLCKD (ketogenic diet) and VLCD (Very-low-calorie-diet) in people with Bariatric Surgery Candidate and Ketogenic Dieting, run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls. Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate, Ketogenic Dieting
- What is being tested?
- VLCKD (ketogenic diet) and VLCD (Very-low-calorie-diet)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of
- 40 kg/m2 with or without comorbidities)
- Roux-en-Y Gastric bypass (RYGB)
Who cannot join
- Weighing over 150kg because this amount is a limitation by the DXA device
- Diabetes mellitus type 1
- Allergic to milk proteins
- A recent history of a heart attack (< 12 months), heart failure or cardiac arrhythmias
- Kidney and/or liver failure (creatinine levels >1.3 mg/dl or liver enzyme levels (AST, ALT, GGT)) less than three times over the upper normal threshold
- Current infectious, sepsis or malignant disease
Show all 11Show fewer
- Rare condition like galactosemia, phenylketonuria or porphyria
- Persistent diarrhoea
- Hypokalaemia, chronic therapies with diuretics as furosemide and hydrochlorothiazide
- Pregnancy or plans to get pregnant in the coming months
- Patients who did not meet criteria to be eligible for bariatric surgery (BMI <35, psychological or unstable psychiatric disorders, inadequate dietary regimen or inadequate exercise pattern which can't be resolved in the upcoming 6 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima Medical Center
Veldhoven, North Brabant, 5500MB
Aliyar Esfandiyari Noushi, MD
About this study
Official title: The Impact of a Preoperative Very Low Calorie Ketogenic Diet (VLCKD) on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls.
Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.
Read the detailed description
According to the World Health Organization, obesity rates have nearly tripled since 1975, resulting in the mortality of four million individuals each year. Obesity contributes to a reduced quality of life and is a significant risk factor for multiple chronic diseases such as type 2 diabetes mellitus, cardiovascular disease, osteoarthritis and certain types of cancer . Bariatric surgery is regarded the most effective treatment for extreme obesity because it achieves significant long-term weight loss and improves or even eliminates obesity-related complications. Based on the American Society for Metabolic and Bariatric surgery, approximately 230.000 bariatric procedures are performed annually, and those procedures predominantly included sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) procedures. Bariatric surgery can be challenging because of an increased thickness of the abdominal wall, the presence of intra-abdominal obesity and hepatomegaly. These anatomical changes are associated with more anaesthetic and surgical manoeuvres during the procedure. Losing weight prior to the procedure is frequently advised because it may help to overcome technical challenges. It may furthermore improve short-term outcomes like surgical time, blood loss, hospital stay and postoperative complications, as well as long-term outcomes like weight loss.
In the preoperative phase, weight loss can be realised by multiple dietary regimens, including low-calorie diets (LCD) (800-1500 kcal/day) and very low-calorie diets (VLCD) (<800 kcal/day). In Máxima Medical Center and a few other hospitals performing bariatric surgery in the Netherlands, the VLCD is the standard diet of choice, which begins two weeks prior to surgery. Systematic reviews reported, as result of these diets, a reduction in liver size (5-20% with a VLCD; 12-27% with a LCD), intrahepatic fat (43% with a VLCD; 40-51% with a LCD) and body weight (2.8-14.8kg with a VLCD; 5.4-23.6kg with a LCD). These diets varied in duration, from two weeks to four months. One of the primary drawbacks of these diets is the loss of metabolically active fat free mass (FFM) and lean body mass (LBM), which are crucial for whole-body protein metabolism, in addition to fat mass (FM). In contrast to FFM, LBM contains bone mass, connective tissue, internal organs and essential fat stored in these tissues. It has been hypothesised that LBM will contain 3 to 5% more fat than FFM. A significant loss of FFM may negatively affect the resting metabolic rate (RMR), slow the rate of weight loss and predispose weight regain in the long-term. A significant loss of FFM, in continuing presence of an excessive FM, may furthermore contribute to sarcopenic obesity. A second important downfall is that some patients may not tolerate a (V)LCD regime due to side-effects leading to poor compliance and subsequently poor weight loss outcomes. For clinical trials, the reported attrition rate for a (V)LCD regime is around 20%, raising concerns about the study validity.
Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. A VLCKD is characterized by a very low carbohydrate content (<50 g/daily), a low-fat content (15-30 g fat/daily) and a high amount of proteins (1-1.5 g protein/kg ideal body weight). The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. In addition, the compliance of patients might be improved by VLCKDs, possibly due to the anorexigenic effect and hunger reduction of ketone bodies. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. A retrospective cohort study found that a three-week lasting VLCKD resulted in more weight loss (5.8kg vs. 4.8kg) compared to a VLCD. In addition, two prospective cohort studies showed as result of a VLCKD, FFM was reduced by 7.6 kg (10.0%) and 0.7kg (1.1%) , whereas FM was reduced by 10.5kg (17.9%) and 5kg (8.8%). What is important to note is that these studies lack a control group, randomisation and are subjected to limitations in FFM and FM measurement due to the use of single-frequency bioelectrical impedance analysis (BIA). Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.
- Conditions
- Bariatric Surgery Candidate, Ketogenic Dieting
- Being tested
- VLCKD (ketogenic diet), VLCD (Very-low-calorie-diet)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLCKD (ketogenic diet)Dietary supplement
Also called VLCKD
diets prior to bariatric surgery
VLCD (Very-low-calorie-diet)Dietary supplement
Also called VLCD
diets prior to bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| VLCD (Very-Low-Calorie-Diet) | Active comparator | Patients in the VLCD group receive, as prescribed by a dietician, three meal sachets a day.
Each meal contains ±240kcal (=1004 kJ), 17-20g carbohydrates and 14-17g proteins.
Altogether, this diet contains less than 800 kcal/day, 50-60g carbohydrates per day and 42-51g protein per day. The diet is continued for 14 days, until the day prior to surgery. In addition to using liquid meals, patients are allowed to consume raw vegetables (e.g., endive, spinach, cucumber, lettuce; without oil or dressings), and clear soups. Patients are advised to drink at least two liters per day of mineral water, tea, infusions or coffee without milk and/or sugar. Receives: Dietary Supplement: VLCD (Very-low-calorie-diet) |
| VLCKD (Very-Low-Calorie-Ketogenic-Diet) | Active comparator | Six meal sachets are given to patients in the VLCKD group each day. A single meal has 16-19g of proteins, 2-3g of carbohydrates, and ±86kcal (=363 kJ). Together, the daily energy intake from this diet is less than 800 kcal, 50 g of carbohydrates, and 100 g of proteins. The diet is followed up to the day before surgery for a total of 14 days. Patients are recommended to ingest vegetables with a low glycaemic load (such as sprouts, lettuce, spinach, and tomatoes) in addition to the liquid meals. Patients are encouraged to consume at least two liters of mineral water, tea, infusions, or coffee without milk or sugar each day. Receives: Dietary Supplement: VLCKD (ketogenic diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FFM (%) in proportion to TBWL
The main outcomes are the change in FFM (percentage) in proportion to total body weight loss (TBWL) measured from baseline to two weeks after start of the diet.
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Secondary outcomes (29)
Change in weight
Weight (in kilograms), measured by Multi-frequency bioelectrical impedance analysis (MF-BIA), measured a total of three times. Twice before surgery: once prior to the diet and once after ending the diet. The last time 3 months after surgery
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Physical activity questionnaire
Measured by International Physical Activity Questionnaire (IPAQ). The IPAQ is used to estimate physical activity levels and to examine if there are differences in comparison to each diet and to assess differences preoperatively and postoperatively during and after completion of the diet.
Measured in minutes per day. With a minimum of 0 minutes up to 1440 minutes a day.
Higher scores might indicate higher levels of activity
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Patient satisfaction assessed by a questionnaire
5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied). To assess the degree of contentment in regard to each diet. Higher scores results in more satisfaction
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Incidence of side effects, assesed by questionnaire
Measured by self-reported questionnaires, making use of a dichotomous scale (Yes; No).
With a score Yes indicating the occurence of a side effect.
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Compliance assesed by return of diet sachets
Via the amount of sachets a patient has used. The patients has to bring the empty sachets along to their appointment. With the amount of sachets we will have insight to how many have been used and to the extent of compliance a patient has shown regarding their dietary intake. More sachets returned mean a possibly a higher compliance
Measured: 2 weeks prior to surgery till the day of surgery
Change in weight
Weight (in kilograms), measured by and Dual energy x-ray absorptiometry (DXA), measured twice before surgery (prior to the diet and after ending the diet) and once three months after surgery.
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Upper extremity muscle strenght
Muscle strength (in kilogram), measured by handgrip peak strength, measured twice before surgery (prior to start diet and after finishing diet) and measured after surgery. Muscle strength is tested to map general upper extremity muscle strength.
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Surgical outcome (1)
Surgical time needed to perform the RYGB. Measured in minutes
Measured: Day of surgery
Surgical outcome (2)
Hospital stay during admission. Measured in days.
Measured: From day of surgery untill the day of discharge, counted as the nights a patient has stayed in the hospital for admission
Surgical outcome (3)
Complications occuring during admission up to 30 days postoperatively. Scored with a yes or no
Measured: Day of surgery up to 30 days postoperatively
Surgical outcome (4)
Re-admissions occuring within 30 days postoperatively. Scored with yes or no
Measured: Day of surgery up to 30 days postoperatively
Biochemical testing- Ketosis
B-hydroxybutyrate measurement in blood. Aim of this test is to measure the degree of ketosis. Elevated levels of B-hydroxybutyrate could indicate a state of ketosis
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes- Sodium)
Sodium. Reference values between 135-145 mmol/L are seen as normal. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes - Potassium)
Potassium. Reference values of 3.5-5.0 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes - Albumin)
Albumin. Reference values of 31-44g/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Aspartate Aminotransferase (AST))
Aspartate Aminotransferase (AST). Reference values of <31 U/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Alanine Transaminase (ALT))
Alanine Transaminase (ALT). Referene values of <34 U/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Gamma glutamyl transpeptidase (GGT))
Gamma glutamyl transpeptidase (GGT). Reference values of <38 U/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney function - Creatinine)
Creatinine. Reference values of 49-90 micromol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney function - Urea)
Urea. Reference values of 2.5-6.4 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney Function - Estimated glomerular filtration rate (eGFR))
Estimated glomerular filtration rate (eGFR). Reference values of >90 ml/min/1.73m2. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Iron)
Iron. Reference values of 9-30 micromol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Hemoglobin)
Hemoglobin. Reference values ranging from 7.5-10 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - Total cholesterol)
Total cholesterol. Reference value < 5mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - low-density lipoprotein (LDL))
Low-density lipoprotein (LDL). Reference value <2.6mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - High-density lipoprotein (HDL))
High-density lipoprotein (HDL). Reference value >1.1 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - Triglycerides)
Triglycerides. Reference value <2.0 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Calcium)
Calcium. Reference values ranging from 2.10-2.55 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Glucose)
Glucose. Reference values ranging from 4.0-7.8 mmol/L. Aim of the biochemical testing is to assess nutritional status
Measured: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Sep 2022
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliyar Esfandiyari Noushi, Maxima Medical Center
- Investigators
- Francois van Dielen, MD PhD, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850493
- Sponsor's protocol ID
- NL81550.015.22
- Status last verified
- Jan 2025
- First submitted
- 30 Jul 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Preoperative Very Low Calorie Ketogenic Diet (VLCKD) on Body Composition in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06850493
- Acronym / sponsor ID
- NL81550.015.22
- Conditions
- Bariatric Surgery Candidate, Ketogenic Dieting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Standard dietary regiments for bariatric are advised prior to surgery. The most used diet is a very low calorie diet (VLCD). These diets potentially have multiple pittfalls.
Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.
Detailed description
According to the World Health Organization, obesity rates have nearly tripled since 1975, resulting in the mortality of four million individuals each year. Obesity contributes to a reduced quality of life and is a significant risk factor for multiple chronic diseases such as type 2 diabetes mellitus, cardiovascular disease, osteoarthritis and certain types of cancer . Bariatric surgery is regarded the most effective treatment for extreme obesity because it achieves significant long-term weight loss and improves or even eliminates obesity-related complications. Based on the American Society for Metabolic and Bariatric surgery, approximately 230.000 bariatric procedures are performed annually, and those procedures predominantly included sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) procedures. Bariatric surgery can be challenging because of an increased thickness of the abdominal wall, the presence of intra-abdominal obesity and hepatomegaly. These anatomical changes are associated with more anaesthetic and surgical manoeuvres during the procedure. Losing weight prior to the procedure is frequently advised because it may help to overcome technical challenges. It may furthermore improve short-term outcomes like surgical time, blood loss, hospital stay and postoperative complications, as well as long-term outcomes like weight loss.
In the preoperative phase, weight loss can be realised by multiple dietary regimens, including low-calorie diets (LCD) (800-1500 kcal/day) and very low-calorie diets (VLCD) (<800 kcal/day). In Máxima Medical Center and a few other hospitals performing bariatric surgery in the Netherlands, the VLCD is the standard diet of choice, which begins two weeks prior to surgery. Systematic reviews reported, as result of these diets, a reduction in liver size (5-20% with a VLCD; 12-27% with a LCD), intrahepatic fat (43% with a VLCD; 40-51% with a LCD) and body weight (2.8-14.8kg with a VLCD; 5.4-23.6kg with a LCD). These diets varied in duration, from two weeks to four months. One of the primary drawbacks of these diets is the loss of metabolically active fat free mass (FFM) and lean body mass (LBM), which are crucial for whole-body protein metabolism, in addition to fat mass (FM). In contrast to FFM, LBM contains bone mass, connective tissue, internal organs and essential fat stored in these tissues. It has been hypothesised that LBM will contain 3 to 5% more fat than FFM. A significant loss of FFM may negatively affect the resting metabolic rate (RMR), slow the rate of weight loss and predispose weight regain in the long-term. A significant loss of FFM, in continuing presence of an excessive FM, may furthermore contribute to sarcopenic obesity. A second important downfall is that some patients may not tolerate a (V)LCD regime due to side-effects leading to poor compliance and subsequently poor weight loss outcomes. For clinical trials, the reported attrition rate for a (V)LCD regime is around 20%, raising concerns about the study validity.
Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. A VLCKD is characterized by a very low carbohydrate content (<50 g/daily), a low-fat content (15-30 g fat/daily) and a high amount of proteins (1-1.5 g protein/kg ideal body weight). The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. In addition, the compliance of patients might be improved by VLCKDs, possibly due to the anorexigenic effect and hunger reduction of ketone bodies. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. A retrospective cohort study found that a three-week lasting VLCKD resulted in more weight loss (5.8kg vs. 4.8kg) compared to a VLCD. In addition, two prospective cohort studies showed as result of a VLCKD, FFM was reduced by 7.6 kg (10.0%) and 0.7kg (1.1%) , whereas FM was reduced by 10.5kg (17.9%) and 5kg (8.8%). What is important to note is that these studies lack a control group, randomisation and are subjected to limitations in FFM and FM measurement due to the use of single-frequency bioelectrical impedance analysis (BIA). Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLCD (Very-Low-Calorie-Diet) | Active comparator | Dietary Supplement: VLCD (Very-low-calorie-diet)Patients in the VLCD group receive, as prescribed by a dietician, three meal sachets a day. Each meal contains ±240kcal (=1004 kJ), 17-20g carbohydrates and 14-17g proteins. Altogether, this diet contains less than 800 kcal/day, 50-60g carbohydrates per day and 42-51g protein per day. The diet is continued for 14 days, until the day prior to surgery. In addition to using liquid meals, patients are allowed to consume raw vegetables (e.g., endive, spinach, cucumber, lettuce; without oil or dressings), and clear soups. Patients are advised to drink at least two liters per day of mineral water, tea, infusions or coffee without milk and/or sugar. |
| VLCKD (Very-Low-Calorie-Ketogenic-Diet) | Active comparator | Dietary Supplement: VLCKD (ketogenic diet)Six meal sachets are given to patients in the VLCKD group each day. A single meal has 16-19g of proteins, 2-3g of carbohydrates, and ±86kcal (=363 kJ). Together, the daily energy intake from this diet is less than 800 kcal, 50 g of carbohydrates, and 100 g of proteins. The diet is followed up to the day before surgery for a total of 14 days. Patients are recommended to ingest vegetables with a low glycaemic load (such as sprouts, lettuce, spinach, and tomatoes) in addition to the liquid meals. Patients are encouraged to consume at least two liters of mineral water, tea, infusions, or coffee without milk or sugar each day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of
- Roux-en-Y Gastric bypass (RYGB)
Key exclusion criteria (11 listed)
- Weighing over 150kg because this amount is a limitation by the DXA device
- Diabetes mellitus type 1
- Allergic to milk proteins
- A recent history of a heart attack (< 12 months), heart failure or cardiac arrhythmias
- Kidney and/or liver failure (creatinine levels >1.3 mg/dl or liver enzyme levels (AST, ALT, GGT)) less than three times over the upper normal threshold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLCKD (ketogenic diet)Also: VLCKDdiets prior to bariatric surgery | Dietary supplement | VLCKD (Very-Low-Calorie-Ketogenic-Diet) |
| VLCD (Very-low-calorie-diet)Also: VLCDdiets prior to bariatric surgery | Dietary supplement | VLCD (Very-Low-Calorie-Diet) |
Primary outcome
Change in FFM (%) in proportion to TBWL
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
The main outcomes are the change in FFM (percentage) in proportion to total body weight loss (TBWL) measured from baseline to two weeks after start of the diet.
29 secondary outcomes
Change in weight
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Physical activity questionnaire
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Patient satisfaction assessed by a questionnaire
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Incidence of side effects, assesed by questionnaire
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Compliance assesed by return of diet sachets
Time frame: 2 weeks prior to surgery till the day of surgery
Change in weight
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Upper extremity muscle strenght
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Surgical outcome (1)
Time frame: Day of surgery
Surgical outcome (2)
Time frame: From day of surgery untill the day of discharge, counted as the nights a patient has stayed in the hospital for admission
Surgical outcome (3)
Time frame: Day of surgery up to 30 days postoperatively
Surgical outcome (4)
Time frame: Day of surgery up to 30 days postoperatively
Biochemical testing- Ketosis
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes- Sodium)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes - Potassium)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Electrolytes - Albumin)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Aspartate Aminotransferase (AST))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Alanine Transaminase (ALT))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Liverfunction - Gamma glutamyl transpeptidase (GGT))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney function - Creatinine)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney function - Urea)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Kidney Function - Estimated glomerular filtration rate (eGFR))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Iron)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Hemoglobin)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - Total cholesterol)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - low-density lipoprotein (LDL))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - High-density lipoprotein (HDL))
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Metabolic profile - Triglycerides)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Calcium)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Biochemical testing (Glucose)
Time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francois van Dielen, MD PhD principal investigator
Maxima Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLCKD (ketogenic diet) and VLCD (Very-low-calorie-diet) in people with Bariatric Surgery Candidate and Ketogenic Dieting, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliyar Esfandiyari Noushi, MD (+31408888550, aliyar.esfandiyarinoushi@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FFM (%) in proportion to TBWL (time frame: 2 weeks prior to surgery, day of surgery and 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.