Low-Carbohydrate Diet for Weight Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a low-carb, higher protein diet, similar to the Atkins program, affects weight loss and health in individuals using semaglutide, a medication that aids weight loss. Participants will follow either a low-carbohydrate or a low-fat diet for three months to determine which is more effective for weight management and improving health markers like blood sugar and heart health. Those who are overweight or obese, currently using semaglutide, and willing to adhere to a specific diet may be suitable for the study. Participants will regularly meet with a dietitian and maintain food diaries to track progress. As an unphased trial, this study provides a unique opportunity to explore personalized diet strategies alongside semaglutide for improved health outcomes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on semaglutide and not taking any other hypoglycemic agents. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that low-carbohydrate diets, like the one under study, are generally safe. Participants on these diets often lose more weight in the short term compared to other diets. Studies have found that these diets can help reduce body weight, body fat, and some risks related to heart disease and diabetes. Most people find low-carb diets easy to follow.
Additionally, semaglutide, the medication used in this study, has FDA approval for other purposes, including weight management, indicating thorough safety testing.
Overall, both the low-carb diet and semaglutide have a good safety record when used individually. However, since this trial combines them, monitoring for any new side effects is important. Always consult a healthcare provider before joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about the low-carbohydrate diet for weight loss because it shifts the body's primary energy source from carbohydrates to fats. Unlike traditional low-fat diets, which focus on reducing fat intake, this diet allows for a higher fat consumption while significantly cutting carbs. This approach aims to encourage the body to burn fat more effectively, potentially leading to quicker and more sustainable weight loss. Additionally, by emphasizing protein and non-starchy vegetables, it may help maintain muscle mass and prevent cravings, which can be challenging with other diets.
What evidence suggests that this trial's treatments could be effective for weight loss?
Research has shown that low-carbohydrate diets, which participants in this trial may follow, can lead to greater short-term weight loss compared to low-fat diets, tested in another arm of this trial. One study found that individuals on low-carb diets lost about 2.6 kg (approximately 5.7 pounds) more than those on low-fat diets after 3 to 4 months. Additionally, a review found that low-carb diets significantly reduced body weight and body mass index (BMI), a measure of body fat based on height and weight. However, weight loss can vary widely among individuals. Overall, low-carb diets are effective for weight loss, particularly in the initial stages.12678
Who Is on the Research Team?
Janice Campbell
Principal Investigator
INQUIS Clinical Research
Are You a Good Fit for This Trial?
This trial is for individuals using the injectable GLP-1 agonist Semaglutide for weight loss. Participants will be randomly assigned to follow either a low-carb, higher-protein diet or a low-fat diet over three months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to follow either a low carb, higher protein diet or a low fat diet for 3 months while taking semaglutide
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low Carbohydrate
- Low Fat
Trial Overview
The study aims to compare the effects of two diets on weight loss and health in patients taking Semaglutide: one group follows a low-carbohydrate, higher-protein diet while another adheres to a low-fat diet.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects randomized to the low-carbohydrate arm will be instructed on a reduced calorie diet (\<1400 kcal/day) consisting of an average macronutrient distribution of 20% carbohydrate, 30% protein and 50% fat with a maximum intake of 40g/day of available (net) carbohydrates (approximately 65-75g total carbohydrates). To complement the provided low carbohydrate shakes and snacks, dietary counselling will focus on choosing sources of protein and non-starchy vegetables
Subjects randomized to the low-fat arm will be instructed on a reduced calorie diet (\<1400 kcal/day) consisting of an average macronutrient distribution of 50% carbohydrate, 20% protein and 30% fat, with a maximum intake of 50g/day of fat. To complement the provided low fat shakes and snacks, dietary counselling will focus on choosing lean sources of protein and carbohydrates, while limiting high fat foods such as oils, nuts, full fat dairy, and fatty meats.
Find a Clinic Near You
Who Is Running the Clinical Trial?
INQUIS Clinical Research
Lead Sponsor
Simply Good Foods USA, Ltd.
Collaborator
Citations
Effectiveness of low‐carbohydrate diets for long‐term ...
LC diets were associated with a significantly higher reduction of body weight at 3‐4 (MD −2.59 [−3.93, −1.25] kg, P = .0001) and 6‐8 months (MD −2.64 [−4.32, − ...
Effects of ketogenic and low-carbohydrate diets on the ...
Overall meta-analysis results indicated that KD/LCD significantly reduced BW, BMI, and BFP, but not FM, in individuals with a carbohydrate intake of ≤100 g/d.
Low-Carbohydrate Diet Macronutrient Quality and Weight ...
This cohort study examines associations of 5 low-carbohydrate diets including macronutrients of differing source and quality with weight ...
Low-carb diet: Can it help you lose weight?
Low-carb diets, especially very low-carb diets, may lead to greater short-term weight loss than do low-fat diets. But most studies have found that at 12 or 24 ...
5.
med.stanford.edu
med.stanford.edu/news/all-news/2018/02/low-fat-or-low-carb-its-a-draw-study-finds.htmlLow-fat or low-carb? It's a draw, study finds - Stanford Medicine
There was still, however, immense weight loss variability among them; some dropped upward of 60 pounds, while others gained close to 15 or 20.
A Randomized Trial of a Low-Carbohydrate Diet for Obesity
Subjects on the low-carbohydrate diet had lost more weight than subjects on the conventional diet at 3 months (mean [±SD], –6.8±5.0 vs. –2.7±3.7 percent of body ...
Effects of Low-Carbohydrate vs Low-Fat Diets on Weight ...
After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean ...
Impact of low-carbohydrate diet on health status
According to this model, low-carbohydrate diets may reduce the risk of obesity, CVDs, T2DM, and cancer by decreasing body weight and increasing ...
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