Time-Restricted Eating for Obesity and Insulin Resistance

(MEDITRE Trial)

Overseen By Candida Rebello, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Steroids, Olanzapine, Clozapine, others

Disqualifiers: Type 2 diabetes, Type 1 diabetes, Renal dysfunction, Malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether time-restricted eating combined with a low-energy dense diet (fewer calories per bite) can reduce insulin resistance and body weight in older adults with obesity. Participants will eat during a 10-hour window and fast for 14 hours. One group will follow a low-energy dense diet, while the other will maintain their usual diet. This trial suits individuals with a body mass index (BMI) of 30 or more who experience insulin resistance but do not have long-term diabetes or significant kidney issues. As an unphased trial, it offers a unique opportunity to explore new dietary approaches to improve health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including systemic steroids, olanzapine, clozapine, prescription medications for obesity, thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin.

What prior data suggests that time-restricted eating is safe for older adults with obesity and insulin resistance?

Research shows that diets low in calorie density, meaning fewer calories per gram of food, are generally easy to follow. Studies have found that reducing calorie intake can enhance energy use without major side effects. For instance, one study discovered that eating less led to a greater reduction in calories burned by the body than could be explained by just losing fat and muscle.

Research on other diets, like low-carb and Mediterranean diets, shows similarities to low-calorie density diets. These studies often find that such diets are safe and can aid in weight loss and metabolism.

Overall, while no specific negative effects are linked to low-calorie density diets, they are generally considered safe and may lead to positive health benefits, such as better weight control and improved insulin function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores time-restricted eating combined with a low-energy dense diet as a unique approach to tackling obesity and insulin resistance. Unlike standard treatments that often rely on calorie counting or medication, this method focuses on when and what you eat to manage weight and improve metabolism. By eating within specific time windows and choosing foods low in energy density, participants may experience weight loss and better insulin sensitivity without the need for more invasive or pharmacological interventions. This approach could offer a more sustainable and less burdensome option for individuals struggling with obesity and related metabolic issues.

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

Research has shown that eating a diet with low-energy dense foods can help people lose weight and improve insulin sensitivity. In this trial, one group of participants will follow a low-energy dense diet combined with time-restricted eating. A study found that people on this diet lost significant weight. They consumed fewer calories daily—about 425 fewer for men and 275 fewer for women—compared to those who ate high-energy dense foods. Choosing low-energy dense foods means selecting foods with fewer calories per gram, which helps control calorie intake. This method has shown promise in managing obesity and related issues like insulin resistance. ^{6 7 8 9 10}

Who Is on the Research Team?

Candida Rebello, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for older adults who are overweight and have insulin resistance. Participants should be willing to follow a time-restricted eating plan, which includes fasting for 14 hours and having a 10-hour window for eating.

Inclusion Criteria

Mini-Mental State Examination (MMSE) > 25

Body mass index (BMI) ≥ 30kg/m2

Geriatric Depression Scale-15 (GDS-15) < 9

Exclusion Criteria

Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)

My weight has changed by more than 3 kg in the last 3 months.

I was diagnosed with Type 2 diabetes over five years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow time-restricted eating with either a low-energy dense diet or the usual diet for 8 weeks

8 weeks

Meals prepared and dispensed, dietary compliance monitored

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-energy dense diet

Trial Overview The study is testing the effects of two diets during time-restricted eating: one group will eat foods with fewer calories per gram (low-energy dense diet), while the other will eat their usual diet. The goal is to see if this affects body weight and insulin resistance.

How Is the Trial Designed?

Group I: Low energy dense diet Experimental Treatment 1 Intervention

Subjects will be required to follow time-restricted eating and receive a diet low in energy density

Group II: Usual diet Active Control 1 Intervention

Subjects will be required to follow time-restricted eating and receive the usual diet.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Published Research Related to This Trial

A pilot study involving 44 adults with overweight/obesity showed that a diet focused on lowering energy density (ED) led to greater weight loss compared to other dietary approaches, with participants losing an average of 20.5 lbs in the Low-ED group.

The Low-ED diet also increased fruit consumption and overall physical activity among participants, indicating that focusing on nutrient-dense foods can improve diet quality while promoting weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an energy density prescription on diet quality and weight loss: a pilot randomized controlled trial. Raynor, HA., Looney, SM., Steeves, EA., et al.[2018]

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 time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

In a study of 513 obese patients over 10.5 months, dietary changes focused on food energy density led to an average weight loss of -0.195 kg/m² per month, with 36% of participants losing more than 5% of their body weight.

After the initial treatment, patients who self-managed their diet continued to lose weight at a rate of -0.053 kg/m² per month over 16.8 months, with those having type 2 diabetes experiencing greater weight loss, suggesting that individualized dietary counseling can lead to sustained weight loss and adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful weight loss and maintenance in everyday clinical practice with an individually tailored change of eating habits on the basis of food energy density. Schusdziarra, V., Hausmann, M., Wiedemann, C., et al.[2021]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

Intermittent energy restriction (IER) shows potential benefits for managing obesity and related health issues, but current evidence does not demonstrate it to be superior to continuous energy restriction (CER).

There is a lack of long-term studies (most under 6 months) on the safety and efficacy of IER, and critical questions remain about its effects on various health metrics and specific populations, indicating a need for personalized approaches in recommending IER.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction, Weight Loss and Cardiometabolic Risk: A Critical Appraisal of Evidence in Humans. Katsarou, AL., Katsilambros, NL., Koliaki, CC.[2023]

Participants on a low energy dense (LED) diet maintained their weight better than those on a usual diet, showing a weight loss of -0.3% compared to a gain of 1.3% over 7 months.

The LED diet also improved cardiovascular health markers, with significant reductions in fasting blood sugar, total cholesterol, and low-density lipoprotein (LDL) cholesterol, indicating its potential benefits for weight maintenance and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low energy density diet, weight loss maintenance, and risk of cardiovascular disease following a recent weight reduction program: A randomized control trial. Karimi, G., Azadbakht, L., Haghighatdoost, F., et al.[2020]

In a study of 156 children aged 4-9 years who are overweight or obese, those consuming lower energy density (ED) diets had significantly higher dietary quality scores, as measured by the Healthy Eating Index-2005 (HEI).

Children on low ED diets also had higher scores for total fruit and vegetable intake and lower saturated fat intake, suggesting that promoting lower ED diets could improve dietary quality in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between dietary energy density and dietary quality in overweight young children: a cross-sectional analysis. Poole, SA., Hart, CN., Jelalian, E., et al.[2018]

In an 18-month weight loss trial with 183 participants, increasing the number of low-energy-dense (LED) foods consumed was linked to significant reductions in body mass index (BMI) and percent weight loss, while simply reducing high-energy-dense (HED) foods did not yield the same results.

Both strategies reduced dietary energy density (ED), but only increasing LED food intake was associated with better weight loss outcomes, suggesting that not all methods of reducing ED are equally effective for weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing low-energy-dense foods and decreasing high-energy-dense foods differently influence weight loss trial outcomes. Vadiveloo, M., Parker, H., Raynor, H.[2019]

The most effective strategy for weight loss is reducing energy intake, rather than just lowering fat content or increasing physical activity without calorie restriction.

Diets low in energy density, which are high in complex carbohydrates and low in fat, allow individuals to eat satisfying portions while consuming fewer calories, promoting sustainable weight loss and healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary approaches to the treatment of obesity. Rolls, BJ., Bell, EA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8017325/

Optimal Diet Strategies for Weight Loss and ... - PubMed Central A low-calorie diet involves consumption of 1,000–1,500 calories per day; deficits of 500–750 calories per day have been used for weight loss and are recommended ...

2. ctv.veeva.com ctv.veeva.com/study/modulating-energy-density-in-time-restricted-eating

Modulating Energy Density in Time-Restricted Eating The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet.

3. withpower.com withpower.com/trial/phase-insulin-resistance-1-2024-560e8

Time-Restricted Eating for Obesity and Insulin Resistance A pilot study involving 44 adults with overweight/obesity showed that a diet focused on lowering energy density (ED) led to greater weight loss compared to ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165%2823%2929469-1/fulltext

Dietary energy density is associated with energy intake and ... Results: Men and women with a low-energy-dense diet had lower energy intakes (≈425 and 275 kcal/d less, respectively) than did those with a high-energy-dense ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004784

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs show modest 3-month glycemic improvements: 0.29% HbA1c reduction. · Cultural context significantly influences low-carb diet metabolic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9036397/

Impact of calorie restriction on energy metabolism in humans Calorie restriction induces a reduction in energy expenditure that is larger than the loss of metabolic mass, ie fat-free mass and fat mass.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612514/

Evidence reviews for the effectiveness of different diets ... - NCBI Evidence on low-carbohydrate diets demonstrated that for almost all outcomes, the diet did not result in improvements in weight, BMI, waist circumference, or ...

8. diabetesjournals.org diabetesjournals.org/care/article/47/6/1074/154508/Effect-of-5-2-Regimens-Energy-Restricted-Diet-or

Effect of 5:2 Regimens: Energy-Restricted Diet or Low-Volume ... Our findings suggest that the 5:2 energy-restricted diet intervention improved glycemic control, body composition, and cardiometabolic ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1220020/full

Weight, insulin resistance, blood lipids, and diet quality ... The DIETFITS trial reported no significant difference in 12-month weight loss between a healthy low-fat and healthy low-carbohydrate diet.

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa0708681

Weight Loss with a Low-Carbohydrate, Mediterranean, or ... A low-carbohydrate diet is a feasible alternative to a low-fat diet for producing weight loss and may have favorable metabolic effects.