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

Trial Summary

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 data supports the effectiveness of the treatment Low-energy dense diet, Low-calorie diet, Low-caloric density diet, Energy-restricted diet for obesity and insulin resistance?

Research shows that diets with low energy density (fewer calories per gram of food) can help with weight loss by allowing people to eat satisfying portions while reducing calorie intake. This approach has been effective in promoting weight loss and improving diet quality, which can be beneficial for managing obesity and related conditions like insulin resistance. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

There is limited high-quality evidence on the long-term safety of time-restricted eating (a form of intermittent energy restriction) in humans. While some studies suggest it may have beneficial effects on health, more research is needed to confirm its safety for the general population. ^{1 2 6 7 8}

How is the low-energy dense diet treatment for obesity and insulin resistance different from other treatments?

The low-energy dense diet focuses on consuming foods that are lower in calories per gram, which can help with weight loss by allowing people to eat larger portions without consuming too many calories. This approach is different from other treatments because it emphasizes the quality and energy density of foods rather than just reducing overall calorie intake. ^{1 2 6 9 10}

What is the purpose of this trial?

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 (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces: 1. Insulin resistance and 2. Body weight. Researchers will compare the groups: 1. Following time-restricted eating and given a diet reduced in energy density or 2. Following time-restricted eating and given a diet typically consumed in this population

Research Team

Candida Rebello, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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) 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]

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]

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]

References

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

The effects of an energy density prescription on diet quality and weight loss: a pilot randomized controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Increasing low-energy-dense foods and decreasing high-energy-dense foods differently influence weight loss trial outcomes. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Relationship between dietary energy density and dietary quality in overweight young children: a cross-sectional analysis. [2018]

4. Germany 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. [2021]

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

Dietary approaches to the treatment of obesity. [2019]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Energy Restriction, Weight Loss and Cardiometabolic Risk: A Critical Appraisal of Evidence in Humans. [2023]

8. India 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. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. [2023]

10. United States 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. [2023]