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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different eating patterns, such as continuous feeding (eating throughout the day) versus intermittent feeding (eating during specific time windows), affect body fat rhythms in individuals with and without obesity. Researchers focus on the body's internal clock and its potential changes in those with obesity. The trial seeks participants who are either of normal weight or have obesity, are not very active, and for females, are not pregnant or breastfeeding. Participants should not have certain sleep issues or work night shifts. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on eating patterns and obesity.

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.

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

Research has shown that both continuous and intermittent eating methods are generally safe for weight loss in adults with obesity. For continuous eating, studies on similar methods like time-restricted eating indicate safety and no negative impact on eating habits. Specifically, eating within an 8-hour period can aid weight loss without causing harm.

For intermittent eating, research indicates it can lead to weight loss and improve health measures like cholesterol levels. Studies have demonstrated moderate reductions in weight and body mass index. These methods are well-tolerated over several weeks to months.

In summary, both eating methods have proven safe and effective for weight loss. Participants in previous studies did not report any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on feeding patterns for obesity because it explores two innovative approaches: continuous feeding and intermittent feeding. Unlike the standard of care, which typically involves calorie restriction and increased physical activity, these methods focus on the timing and frequency of food intake. Continuous feeding aims to manage weight by providing a steady intake of nutrients, while intermittent feeding alternates between periods of eating and fasting, potentially boosting metabolism and improving insulin sensitivity. By examining these feeding patterns, researchers hope to uncover new strategies for effective obesity management that could improve metabolic health and weight control.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare two feeding patterns: intermittent feeding and continuous feeding. Studies have shown that intermittent fasting, one of the methods under study, can aid in weight loss and improve overall health. Research indicates that intermittent fasting is linked to successful weight loss and can reduce body weight and body mass index (BMI). It also positively affects cholesterol levels and other health indicators. In contrast, continuous feeding, the other method tested in this trial, is effective for weight management but does not offer better long-term benefits than intermittent fasting. Both methods can help manage obesity, but intermittent fasting might provide additional health benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Participants with obesity Active Control 2 Interventions

Group II: Normal weight participants 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+

Published Research Related to This Trial

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) 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, 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]

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