Weight Loss for a Healthier You Programme

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ketogenic Dieting, Weight Loss, Obesity, Metabolic Syndrome

Intervention / Treatment
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* Other: Calorie-Restricted Healthy Ketogenic Diet
* Other: Calorie-Restricted Low Fat Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 27.5 to 40 kg/m2 Aged 21 to 65 years Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Ketogenic Diet (HKD)<br>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. | Other: Calorie-Restricted Healthy Ketogenic Diet<br>* 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.<br>* Other names: Very Low Carbohydrate Diet;|
| Active Comparator: Low Fat caloric-restricted Diet (LFD)<br>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. | Other: Calorie-Restricted Low Fat Diet<br>* Participants will be advised on Calorie-restricted Low Fat diet via 7 workshops.<br>* Other names: Weight loss diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight changes post intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight changes at follow up appointments | 3 months and 1 year | 
| Blood pressure | Systolic and diastolic changes at follow up appointments | 3 months, 6 months, 1 year | 
| Hemoglobin A1c | HbA1c changes at follow up appointments | 3 months, 6 months, 1 year | 
| Fasting blood glucose | Fasting blood glucose changes at follow up appointments | 3 months, 6 months, 1 year | 
| Total cholesterol | Cholesterol changes at follow up appointments | 3 months, 6 months, 1 year | 
| Low-density lipoprotein cholesterol | Cholesterol changes at follow up appointments | 3 months, 6 months, 1 year | 
| High-density lipoprotein cholesterol | Cholesterol changes at follow up appointments | 3 months, 6 months, 1 year | 
| Triglycerides | Triglycerides changes at follow up appointments | 3 months, 6 months, 1 year | 
| Alanine transaminase | ALT changes at follow up appointments | 3 months, 6 months, 1 year | 
| Aspartate transaminase | AST changes at follow up appointments | 3 months, 6 months, 1 year | 
| Plasma 3-hydroxybutyrate (3-OHB) | Blood ketones at follow up appointments | 3 months, 6 months, 1 year | 
| Dietary intake | Nutrients intake by assessing 2-day food diaries | 3 months, 6 months, 1 year | 
| Physical activity | Physical activity frequency and intensity via self-reported questionnaire | 3 months, 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low carbohydrates, mHealth, Randomized controlled trial