Ketogenic DietingNCT05049954
Weight Loss for a Healthier You Programme
A study testing Calorie-Restricted Healthy Ketogenic Diet and Calorie-Restricted Low Fat Diet in people with Ketogenic Dieting and Weight Loss, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
In view of the research gap in the safety of traditional ketogenic diet, there is a need for a healthy alternative to the ketogenic diet that reduces the individual's propensity to adverse diet choices. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Weight Loss, Obesity
- What is being tested?
- Calorie-Restricted Healthy Ketogenic Diet and Calorie-Restricted Low Fat Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Oct 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 27.5 to 40 kg/m2
- Aged 21 to 65 years
Who cannot join
- Individuals with type 1 diabetes or type 2 diabetes on insulin
- heart failure
- active cancer or in remission for less than 5 years
- advanced kidney disease
- hypothyroidism
- pregnancy
- depression
- untreated anemia, known thalassaemia, or other blood disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Healthy Ketogenic Diet Versus Calorie-restricted Low Fat Diet on Weight Loss and Metabolic Outcomes for Obesity: A Randomised Controlled Trial
In view of the research gap in the safety of traditional ketogenic diet, there is a need for a healthy alternative to the ketogenic diet that reduces the individual's propensity to adverse diet choices. Healthy guidelines to be adopted include a diet low in saturated fat, trans fat, and sugar, along with adequate fibre. Potentially with these guidelines in effect, the associated risks for CVD would be reduced. Therefore, this study will investigate the effect of a calorie-restricted healthy ketogenic diet versus a calorie-restricted low fat diet on weight loss and metabolic outcomes among individuals with obesity.
Read the detailed description
The ketogenic diet has recently gained popularity as an effective dietary plan for weight management. Some of the cited benefits include a reduction in appetite and hunger, as well as improvements in fat oxidation leading to weight loss. Remarkably, some studies have also demonstrated increases in high-density lipoprotein (HDL) cholesterol and decreases in triglyceride levels, which point to a reduction in cardiovascular disease (CVD) risk.
In spite of these, there are still widespread concerns regarding the potentially high proportion of total and saturated fats derived from ketogenic diets owing to the high-fat and moderate-protein nature. These are associated with elevated low-density lipoprotein (LDL) cholesterol levels which may offset the purportedly lower CVD risk, especially in obese individuals. Furthermore, few randomised controlled trials (RCTs) have placed emphasis on the reduction of saturated fat, leading to confounding effects on the safety of the traditional ketogenic diet. To address the research gap, our study aims to assess the effect of a calorie-restricted healthy ketogenic diet, as compared to a calorie-restricted low fat diet on weight loss and metabolic outcomes among Asian individuals with obesity.
In this randomized controlled trial, participants will be randomly assigned to either the healthy ketogenic diet (HKD) or low fat calorie-restricted diet (LFD) using computer-generated random sequencing. Both the HKD and LFD groups will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period.
The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. All participants are to provide for their own meals and follow a calorie-restricted diet with emphasis on the consumption of healthy fats and the reduction of saturated and trans fats in both diets.
Participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35). Calorie prescriptions for both diets were calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss. Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations.
- Conditions
- Ketogenic Dieting, Weight Loss, Obesity, Metabolic Syndrome
- Being tested
- Calorie-Restricted Healthy Ketogenic Diet, Calorie-Restricted Low Fat Diet
- Keywords
- Low carbohydrates, mHealth, Randomized controlled trial
- Medical subject headings
- Weight Loss, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie-Restricted Healthy Ketogenic DietOther
Also called Very Low Carbohydrate Diet
Participants in the experimental group will be advised on a Calorie-restricted Healthy Ketogenic Diet via 7 workshops. Participants will also be advised to monitor their urinary ketones to track compliance.
Calorie-Restricted Low Fat DietOther
Also called Weight loss diet
Participants will be advised on Calorie-restricted Low Fat diet via 7 workshops.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Ketogenic Diet (HKD) | Experimental | Participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily, with calorie prescriptions calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss.
Participants will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period (total of 7 workshops). Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations during the 6 months period. The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. Receives: Other: Calorie-Restricted Healthy Ketogenic Diet |
| Low Fat caloric-restricted Diet (LFD) | Active comparator | Participants in the reference group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35), with calorie prescriptions calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss.
Similar to the experimental group, participants will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period (total of 7 workshops). Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations during the 6 months period. The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. Receives: Other: Calorie-Restricted Low Fat Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight changes post intervention
Measured: 6 months
Secondary outcomes (13)
Body weight
Weight changes at follow up appointments
Measured: 3 months and 1 year
Blood pressure
Systolic and diastolic changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Hemoglobin A1c
HbA1c changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Fasting blood glucose
Fasting blood glucose changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Total cholesterol
Cholesterol changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Low-density lipoprotein cholesterol
Cholesterol changes at follow up appointments
Measured: 3 months, 6 months, 1 year
High-density lipoprotein cholesterol
Cholesterol changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Triglycerides
Triglycerides changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Alanine transaminase
ALT changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Aspartate transaminase
AST changes at follow up appointments
Measured: 3 months, 6 months, 1 year
Plasma 3-hydroxybutyrate (3-OHB)
Blood ketones at follow up appointments
Measured: 3 months, 6 months, 1 year
Dietary intake
Nutrients intake by assessing 2-day food diaries
Measured: 3 months, 6 months, 1 year
Physical activity
Physical activity frequency and intensity via self-reported questionnaire
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized controlled trial, participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35).
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su Lin Lim, PhD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049954
- Sponsor's protocol ID
- 2021/00833
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will remain confidential and only accessible via lock and keys by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Healthy Ketogenic Diet Versus Calorie-restricted Low Fat Diet on Weight Loss and Metabolic Outcomes for Obesity: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05049954
- Acronym / sponsor ID
- 2021/00833
- Conditions
- Ketogenic Dieting, Weight Loss, Obesity, Metabolic Syndrome
- Keywords
- Low carbohydrates, mHealth, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Sep 2021 (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.
In view of the research gap in the safety of traditional ketogenic diet, there is a need for a healthy alternative to the ketogenic diet that reduces the individual's propensity to adverse diet choices. Healthy guidelines to be adopted include a diet low in saturated fat, trans fat, and sugar, along with adequate fibre. Potentially with these guidelines in effect, the associated risks for CVD would be reduced. Therefore, this study will investigate the effect of a calorie-restricted healthy ketogenic diet versus a calorie-restricted low fat diet on weight loss and metabolic outcomes among individuals with obesity.
Detailed description
The ketogenic diet has recently gained popularity as an effective dietary plan for weight management. Some of the cited benefits include a reduction in appetite and hunger, as well as improvements in fat oxidation leading to weight loss. Remarkably, some studies have also demonstrated increases in high-density lipoprotein (HDL) cholesterol and decreases in triglyceride levels, which point to a reduction in cardiovascular disease (CVD) risk.
In spite of these, there are still widespread concerns regarding the potentially high proportion of total and saturated fats derived from ketogenic diets owing to the high-fat and moderate-protein nature. These are associated with elevated low-density lipoprotein (LDL) cholesterol levels which may offset the purportedly lower CVD risk, especially in obese individuals. Furthermore, few randomised controlled trials (RCTs) have placed emphasis on the reduction of saturated fat, leading to confounding effects on the safety of the traditional ketogenic diet. To address the research gap, our study aims to assess the effect of a calorie-restricted healthy ketogenic diet, as compared to a calorie-restricted low fat diet on weight loss and metabolic outcomes among Asian individuals with obesity.
In this randomized controlled trial, participants will be randomly assigned to either the healthy ketogenic diet (HKD) or low fat calorie-restricted diet (LFD) using computer-generated random sequencing. Both the HKD and LFD groups will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period.
The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. All participants are to provide for their own meals and follow a calorie-restricted diet with emphasis on the consumption of healthy fats and the reduction of saturated and trans fats in both diets.
Participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35). Calorie prescriptions for both diets were calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss. Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this randomized controlled trial, participants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35).
| Arm | Type | Receives |
|---|---|---|
| Healthy Ketogenic Diet (HKD) | Experimental | Other: Calorie-Restricted Healthy Ketogenic DietParticipants in the HKD group will be advised to follow a calorie-restricted healthy ketogenic diet (n=35), with a maximum of 50g net carbohydrate intake daily, with calorie prescriptions calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss. Participants will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period (total of 7 workshops). Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations during the 6 months period. The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. |
| Low Fat caloric-restricted Diet (LFD) | Active comparator | Other: Calorie-Restricted Low Fat DietParticipants in the reference group will be instructed to follow a calorie-restricted low fat diet (LFD) (n=35), with calorie prescriptions calculated based on the Schofield equation, adjusted with a deficit of 500 kcal daily to promote weight loss. Similar to the experimental group, participants will attend group workshops conducted by dietitians at weeks 1, 3, 5, 7, and thereafter at 6-week intervals over the course of a 6-month period (total of 7 workshops). Participants will also be recommended to use the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, steps count and to aid in their adherence to the diet and physical activity recommendations during the 6 months period. The participants will be recommended to achieve their incremental daily step count goal from 3,000, 7,000 to 10,000 to promote increased physical activity, as per their tolerance. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 27.5 to 40 kg/m2
- Aged 21 to 65 years
Key exclusion criteria (8 listed)
- Individuals with type 1 diabetes or type 2 diabetes on insulin
- heart failure
- active cancer or in remission for less than 5 years
- advanced kidney disease
- hypothyroidism
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 |
|---|---|---|
| Calorie-Restricted Healthy Ketogenic DietAlso: Very Low Carbohydrate DietParticipants in the experimental group will be advised on a Calorie-restricted Healthy Ketogenic Diet via 7 workshops. Participants will also be advised to monitor their urinary ketones to track compliance. | Other | Healthy Ketogenic Diet (HKD) |
| Calorie-Restricted Low Fat DietAlso: Weight loss dietParticipants will be advised on Calorie-restricted Low Fat diet via 7 workshops. | Other | Low Fat caloric-restricted Diet (LFD) |
Primary outcome
Body weight
Time frame: 6 months
Weight changes post intervention
13 secondary outcomes
Body weight
Time frame: 3 months and 1 year
Blood pressure
Time frame: 3 months, 6 months, 1 year
Hemoglobin A1c
Time frame: 3 months, 6 months, 1 year
Fasting blood glucose
Time frame: 3 months, 6 months, 1 year
Total cholesterol
Time frame: 3 months, 6 months, 1 year
Low-density lipoprotein cholesterol
Time frame: 3 months, 6 months, 1 year
High-density lipoprotein cholesterol
Time frame: 3 months, 6 months, 1 year
Triglycerides
Time frame: 3 months, 6 months, 1 year
Alanine transaminase
Time frame: 3 months, 6 months, 1 year
Aspartate transaminase
Time frame: 3 months, 6 months, 1 year
Plasma 3-hydroxybutyrate (3-OHB)
Time frame: 3 months, 6 months, 1 year
Dietary intake
Time frame: 3 months, 6 months, 1 year
Physical activity
Time frame: 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No. Individual participant data will remain confidential and only accessible via lock and keys by the researchers.
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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. This study is not recruiting at the moment.
Su Lin Lim, PhD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie-Restricted Healthy Ketogenic Diet and Calorie-Restricted Low Fat Diet in people with Ketogenic Dieting and Weight Loss, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 6 months). 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 23 Sep 2022.