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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Intermittent Fasting for Body Fat Reduction?

Some studies suggest that preoperative dietary interventions, like low-calorie diets, can improve surgical outcomes by reducing blood loss and operating time, which may indirectly support the effectiveness of intermittent fasting for body fat reduction. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Intermittent fasting, which involves restricting food intake on certain days or during certain hours, has been studied in adults with overweight or obesity and is generally considered safe. Studies have shown it can be a feasible and acceptable way to manage weight without causing harmful effects. ^{6 7 8 9 10}

How does intermittent fasting differ from other weight loss treatments?

Intermittent fasting is unique because it focuses on timing of eating rather than just reducing calories, allowing periods of eating and fasting, which can improve metabolic health and aid in weight loss. This approach contrasts with continuous calorie reduction, which involves consistently eating fewer calories every day. ^{1 11 12 13 14}

What is the purpose of this trial?

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

Research Team

Gurinder Bains, PhD

Principal Investigator

Loma Linda University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

FASTING IN ELECTIVE SURGICAL PATIENTS: COMPARISON AMONG THE TIME PRESCRIBED, PERFORMED AND RECOMMENDED ON PERIOPERATIVE CARE PROTOCOLS. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Elective Surgery in Adult Patients with Excess Weight: Can Preoperative Dietary Interventions Improve Surgical Outcomes? A Systematic Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a supervised inpatient low-calorie diet program for massive weight loss prior to RYGB in superobese patients. [2021]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Preoperative fasting abbreviation (Enhanced Recovery After Surgery protocol) and effects on the metabolism of patients undergoing gynecological surgeries under spinal anesthesia: A randomized clinical trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Rationale for novel intermittent dieting strategies to attenuate adaptive responses to energy restriction. [2019]

9. United States 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]

11. Spain pubmed.ncbi.nlm.nih.gov

Preoperative weight loss in patients with indication of bariatric surgery: which is the best method? [2013]

12. United States pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Approach to Medical Weight Loss Prior to Complex Abdominal Wall Reconstruction: Is it Feasible? [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Very low energy diets before nonbariatric surgery: A systematic review and meta-analysis. [2023]

14. Poland pubmed.ncbi.nlm.nih.gov

Validity and efficacy of diets used for preoperative weight reduction among patients qualified for bariatric surgery. [2021]