Intermittent Fasting for Body Fat Reduction

Overseen By Gurinder Bains, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Diabetes, Metabolic syndrome

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if intermittent fasting, a weight loss intervention, can reduce body fat and improve quality of life. Participants will be divided into two groups: one will follow a 16-hour daily fasting routine, while the other will eat as usual. Both groups will maintain their normal exercise habits. Individuals who are generally healthy and do not have diabetes or metabolic syndrome (conditions affecting energy processing) are suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance weight management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that intermittent fasting is generally safe for most people. Studies have found that it can aid in weight loss without causing serious side effects. For instance, one study reported no major health issues when participants followed an intermittent fasting plan, and they lost between 0.8% to 13.0% of their starting weight. This suggests that fasting might be a safe and effective way to reduce body fat.

In intermittent fasting, individuals typically fast for a set period, such as 16 hours, and then eat during the remaining hours. Although this means eating less often, many study participants managed it well without major problems. Those considering joining a trial may find this information helpful in understanding the safety of intermittent fasting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent fasting for body fat reduction because it offers a unique approach compared to traditional weight loss methods like calorie counting or low-carb diets. Instead of focusing on what you eat, intermittent fasting emphasizes when you eat, allowing for a more flexible eating pattern. This method can potentially help improve metabolic health by giving the body longer periods to burn fat. Additionally, it may be easier to stick to since it doesn't involve complex meal planning or strict dietary restrictions.

What evidence suggests that intermittent fasting could be effective for body fat reduction?

This trial will compare intermittent fasting with non-fasting to evaluate their effects on body fat reduction. Research has shown that intermittent fasting can help reduce body fat. In one study, participants lost between 3.4% and 10.6% of their body weight through intermittent fasting. Another study found it might be slightly more effective than regular dieting for weight loss and heart health. Intermittent fasting also lowers cholesterol and BMI, a measure of body fat based on height and weight. Overall, intermittent fasting is a promising method for reducing body fat and improving health. ^{1 2 3 4 6}

Who Is on the Research Team?

Gurinder Bains, PhD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study examining the effects of intermittent fasting on body fat reduction and life quality. People with metabolic syndrome or diabetes cannot join.

Inclusion Criteria

In good health

Exclusion Criteria

History of Metabolic Syndrome

I have a history of diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Non-Fasting

Participants will keep their normal food intake with no restrictions on when to eat and maintain their normal weekly exercise routine

4 weeks

1 visit (in-person) for body fat analysis and questionnaires

Fasting

Participants will follow an intermittent fasting program, fasting for 16 hours and eating during an 8-hour window, while maintaining their normal weekly exercise routine

4 weeks

1 visit (in-person) for body fat analysis and questionnaires

Follow-up

Participants are monitored for changes in body fat and quality of life after the fasting period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fasting
• Non-fasting

Trial Overview The study is testing whether not eating food for certain periods (intermittent fasting) can help reduce body fat and improve how good participants feel about their lives compared to those who do not fast.

How Is the Trial Designed?

Group I: Fasting Experimental Treatment 1 Intervention

For four weeks: Fasting for 16 hours from participant last meal of the previous evening's meal to the first meal of the next day. Then for 8 hours, participant is able to eat. During the fasting, participants are allowed to consume water and black coffee/tea. Participants will also keep their normal weekly exercise routine.

Group II: Non Fasting Active Control 1 Intervention

For four week: Participants will keep their normal food intake with no restrictions on when to eat. Participants will keep their normal weekly exercise routine.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

In a study of 65 patients undergoing elective digestive surgeries, the actual fasting time before surgery averaged 16 hours, which was significantly longer than the prescribed 11 hours, indicating a need for better adherence to fasting protocols.

Prolonged fasting led to increased discomfort from hunger and thirst, especially in the postoperative period, suggesting that implementing a preoperative fasting abbreviation protocol could enhance patient recovery and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FASTING IN ELECTIVE SURGICAL PATIENTS: COMPARISON AMONG THE TIME PRESCRIBED, PERFORMED AND RECOMMENDED ON PERIOPERATIVE CARE PROTOCOLS. Francisco, SC., Batista, ST., Pena, Gd.[2023]

A dietitian-led preoperative very low calorie diet resulted in clinically significant weight loss (average of 7.1 kg) for 141 patients with obesity, which improved their American Society of Anesthesiologists scores and reduced estimated surgical risks.

The median risk of serious postoperative complications decreased from 4.8% to 3.9% and the risk of any complications from 6% to 5.1%, indicating that this dietary intervention may enhance safety for patients undergoing non-bariatric elective surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a dietitian-led very low calorie diet clinic on perioperative risk for patients with obesity awaiting elective, non-bariatric surgery: A retrospective cohort study. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

Intermittent energy restriction (IER) was found to be a feasible and effective weight management strategy for adolescents aged 12-17 with obesity, leading to a significant reduction in BMI %95th percentile after 12 weeks (-5.6%) and maintained reductions at 26 weeks.

Participants reported IER as easy and pleasant to follow, indicating high acceptability, and the intervention also resulted in improvements in cardiovascular health markers, such as reduced carotid intima-media thickness and improved flow-mediated dilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. Jebeile, H., Gow, ML., Lister, NB., et al.[2023]

A literature review involving 371 patients indicated that very low calorie diets and intragastric balloon placements resulted in greater weight loss compared to low calorie diets, although they were associated with slightly higher morbidity and costs.

Very low calorie diets were found to be more effective and quicker for preoperative weight loss than low calorie diets, while also being cheaper and having fewer side effects compared to the intragastric balloon option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative weight loss in patients with indication of bariatric surgery: which is the best method? Adrianzén Vargas, M., Cassinello Fernández, N., Ortega Serrano, J.[2013]

Intermittent energy restriction (IER), such as intermittent fasting, does not lead to greater weight loss compared to continuous energy restriction (CER), where daily energy intake is consistently limited.

Achieving energy balance during refeeding phases of IER may enhance weight loss outcomes, as some studies suggest that this approach could mitigate adaptive responses that hinder ongoing weight loss, although results from existing trials are mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction. Sainsbury, A., Wood, RE., Seimon, RV., et al.[2019]

In a study involving 46 women with overweight/obesity, both continuous energy restriction (CER) and intermittent energy restriction (IER) led to similar weight loss of at least 5% without significant differences in body composition or appetite changes.

Both weight loss strategies improved eating behavior traits, such as dietary restraint and craving control, indicating that neither approach resulted in compensatory increases in appetite or overeating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matched Weight Loss Through Intermittent or Continuous Energy Restriction Does Not Lead To Compensatory Increases in Appetite and Eating Behavior in a Randomized Controlled Trial in Women with Overweight and Obesity. Beaulieu, K., Casanova, N., Oustric, P., et al.[2023]

Intermittent energy restriction (IER) strategies, such as intermittent fasting and time-restricted feeding, show similar effectiveness in weight loss compared to continuous energy restriction (CER) in adults with obesity, based on a review of randomized trials lasting at least 8 weeks.

Out of 11 studies analyzed, 9 found no significant differences in weight or body fat loss between IER and CER, suggesting that IER can be a viable alternative for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Rynders, CA., Thomas, EA., Zaman, A., et al.[2021]

Alternate-day fasting (ADF) is a safe and well-tolerated weight loss method, with 93% of participants completing the 8-week study without adverse effects.

While ADF and a standard caloric restriction diet produced similar weight loss results after 8 weeks, ADF showed more favorable changes in body composition, particularly in fat and lean mass, during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Catenacci, VA., Pan, Z., Ostendorf, D., et al.[2019]

Preoperative very low calorie diets (≤800 kcal) or low calorie diets (≤900 kcal) for one to three weeks can significantly improve surgical outcomes for patients with excess weight/obesity, including reduced blood loss and shorter operating times in procedures like laparoscopic cholecystectomy and liver resection.

The review included 14 studies, highlighting that while these dietary interventions can enhance certain surgical outcomes, more randomized controlled trials are needed to assess their impact on a broader range of surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective Surgery in Adult Patients with Excess Weight: Can Preoperative Dietary Interventions Improve Surgical Outcomes? A Systematic Review. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7021351/

Intermittent fasting and weight loss: Systematic review - PMC Four studies combined fasting and calorie restriction on the non-fasting days and found comparable weight loss to other studies (3.4% to 10.6%). In a direct ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930668/

Evaluation of the effectiveness of intermittent fasting versus ... IF appears to be slightly advantageous over ER in terms of body weight, cardiometabolic factors, and plasma glucose levels.

3. bmj.com bmj.com/content/389/bmj-2024-082007

Intermittent fasting strategies and their effects on body ... The current evidence provides some indication that intermittent fasting diets have similar benefits to continuous energy restriction for weight loss and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1279770724002392

Effectiveness of an intermittent fasting diet versus regular ... IF had a reduction in body weight, BMI, fat mass, and TG in adults aged over 40 with obesity without metabolic disease compared to RD.

5. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-025-01178-6

The impact of intermittent fasting on body composition and ... A systematic review and meta-analysis of randomized controlled trials of IF showed that IF effectively lowered TC and LDL, and reduced BW, BMI, ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... Body Composition​​ The body fat mass at 12 months was reduced by 5.9 kg (95% CI, −7.1 to −4.7) from baseline in the time-restricted–eating group ...