Feeding Patterns for Obesity

Overseen By Kelli A Lytle, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Sleep medications

Disqualifiers: Smoking, Insomnia, Sleep apnea, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial excludes people who have a history of taking medications that affect fat or lipid metabolism, so you may need to stop such medications to participate.

What data supports the effectiveness of the treatment Continuous Feeding, Intermittent Feeding for obesity?

Research shows that intermittent energy restriction, which includes intermittent fasting and time-restricted feeding, is as effective as continuous energy restriction for weight loss in people with obesity. Most studies found no significant difference in weight or body fat loss between these methods. ^{1 2 3 4 5}

Is intermittent fasting safe for humans?

Intermittent fasting (IF) has been studied for its effects on weight and health, but there is not enough information about its long-term safety in different groups of people. Short-term studies suggest it is generally safe, but more research is needed to understand its long-term effects. ^{1 2 6 7 8}

How does the treatment of intermittent feeding differ from other obesity treatments?

Intermittent feeding, which involves restricting eating to certain times or days, is unique because it offers an alternative to continuous calorie restriction by allowing periods of normal eating, potentially making it more flexible and easier to adhere to for some people. Unlike traditional methods, it focuses on when you eat rather than just how much, which can lead to similar weight loss results. ^{1 2 9 10 11}

What is the purpose of this trial?

The goal of this study is to understand the underlying circadian rhythms in subcutaneous adipose tissue of humans with our without continuous feeding and how these are altered in people who have obesity.

Eligibility Criteria

This trial is for sedentary adults with a BMI of 20-25 or 30-37 kg/m2. Men must have a waist-to-hip ratio ≥0.95 and women ≥0.90 if obese. Participants should not be pregnant, breastfeeding, allergic to lidocaine, on lipid-metabolism meds, smokers, night/shift workers, extreme chronotypes (morning/evening persons), or using sleep medications.

Inclusion Criteria

BMI 20-25 kg/m2 or 30-37 kg/m2

I lead a mostly inactive lifestyle.

My waist-to-hip ratio is above the threshold for my gender.

Exclusion Criteria

Allergy to lidocaine

I have taken medication that affects fat metabolism.

I have sleep apnea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Inpatient Study

Participants are admitted to the clinical research unit for controlled feeding and adipose tissue biopsies

3 days

1 visit (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after the inpatient study

4 weeks

Treatment Details

Interventions

• Continuous Feeding
• Intermittent Feeding

Trial Overview The study investigates how continuous versus intermittent feeding affects the circadian rhythms in subcutaneous adipose tissue in individuals with normal weight and obesity. It aims to understand changes in these rhythms due to different feeding patterns.

Participant Groups

Group I: Normal weight participants Active Control 2 Interventions

Group II: Participants with obesity Active Control 2 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

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, which includes methods like alternate day fasting, was found to be more effective than no treatment for weight loss in overweight and obese adults, with an average loss of 4.14 kg over the study period.

However, when compared to continuous energy restriction, intermittent energy restriction did not show a significant difference in weight loss, indicating that both approaches may be similarly effective for short-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis. Harris, L., Hamilton, S., Azevedo, LB., et al.[2022]

Intermittent fasting (IF) may be an effective weight management strategy for overweight and obese adults, but its evidence base in humans is still limited, with only one published systematic review available.

Current guidelines from the National Institute for Health and Care Excellence (NICE) do not recommend very low calorie diets (VLCD) as a routine treatment for obesity, highlighting concerns about potential side effects and the sustainability of fasting approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. Jane, L., Atkinson, G., Jaime, V., et al.[2022]

Intermittent fasting, including methods like the 5:2 diet and time-restricted feeding, shows similar weight loss efficacy to standard daily calorie restriction, but many fasting models do not involve strict fasting cycles or complete fasting.

Longer fasting durations, particularly those extending beyond 16 hours, may enhance benefits like fat loss and improved insulin sensitivity, suggesting that the physiological effects of fasting could be more pronounced with sustained fasting periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. Templeman, I., Gonzalez, JT., Thompson, D., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of intermittent fasting for weight loss in individuals with obesity: A meta-analysis of randomized controlled trials. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review protocol. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

[Intermittent fasting in science and practice; what are the effects on weight and cardiometabolic health?] [2021]

7. England pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]

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

Controlling access time to a high-fat diet during the inactive period protects against obesity in mice. [2014]

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

Meal pattern alterations associated with intermittent fasting for weight loss are normalized after high-fat diet re-feeding. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence and Dietary Composition during Intermittent vs. Continuous Calorie Restriction: Follow-Up Data from a Randomized Controlled Trial in Adults with Overweight or Obesity. [2021]

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

Intermittent fasting reduces body fat but exacerbates hepatic insulin resistance in young rats regardless of high protein and fat diets. [2018]