Weight Loss for a Healthier You Programme
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
1 other identifier
interventional
70
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedSeptember 23, 2022
September 1, 2021
1.2 years
September 9, 2021
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body weight
Weight changes post intervention
6 months
Secondary Outcomes (13)
Body weight
3 months and 1 year
Blood pressure
3 months, 6 months, 1 year
Hemoglobin A1c
3 months, 6 months, 1 year
Fasting blood glucose
3 months, 6 months, 1 year
Total cholesterol
3 months, 6 months, 1 year
- +8 more secondary outcomes
Study Arms (2)
Healthy Ketogenic Diet (HKD)
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Participants will be advised on Calorie-restricted Low Fat diet via 7 workshops.
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 27.5 to 40 kg/m2
- Aged 21 to 65 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Hospital
Singapore, 119074, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Su Lin Lim, PhD
National University Hospital, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- It is not feasible to apply blinding to the study design due to the nature of the intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
September 20, 2021
Study Start
October 1, 2021
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
September 23, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will remain confidential and only accessible via lock and keys by the researchers.