What side effects are associated with this type of intervention?

Intermittent Energy Restriction (IER) combined with a Mediterranean Diet (MED) can lead to side effects such as hunger, irritability, fatigue, and difficulty concentrating, especially during the initial adjustment period. The Mediterranean diet, while generally well-tolerated, may cause gastrointestinal discomfort due to its high fiber content and can lead to increased caloric intake if not monitored properly. These treatments aim to reduce central obesity and improve metabolic health, but individual responses can vary.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for obesity that may indirectly address abdominal obesity through mechanisms promoting fat metabolism and weight reduction. These include orlistat, which inhibits fat absorption, and GLP-1 receptor agonists like liraglutide and semaglutide, which enhance insulin secretion, reduce appetite, and promote weight loss. While these treatments do not specifically combine intermittent energy restriction with the Mediterranean diet, they share the goal of reducing central obesity and improving metabolic health.

What other types of research exist?

Promising alternatives to IER+MED for treating abdominal obesity include: 1) Continuous Energy Restriction (CER) with a balanced diet, which involves a consistent daily caloric deficit and has shown efficacy in weight loss and metabolic improvements. 2) High-Protein, Low-Carbohydrate Diets, which can enhance satiety and promote fat loss, particularly visceral fat. 3) Bariatric Surgery, such as Roux-en-Y gastric bypass or sleeve gastrectomy, which has been effective in significant weight loss and reduction of obesity-related comorbidities. 4) Intensive Lifestyle Interventions, combining diet, physical activity, and behavioral therapy, which have demonstrated long-term benefits in weight management and metabolic health.

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Behavioral Intervention

Diets for Reducing Abdominal Fat in Obesity ((HDLS2) Trial)

N/A

Recruiting

Led By Loic Le Marchand, MD, PhD

Research Sponsored by University of Hawaii

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Antibiotic use in past 3 months

Age 35-69 years old

Must not have

Diagnosis of Type 1 diabetes or Type 2 diabetes and taking insulin for treatment

Diagnosis of thyroid conditions under treatment with hormones or medications.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a diet where people eat much less for a few days and follow a healthy Mediterranean diet for the rest of the time. It targets middle-aged adults from specific ethnic groups with high levels of harmful fat. The goal is to encourage the body to burn more fat, especially around the belly and liver.

Who is the study for?

Adults aged 35-69 with a BMI of 25-40 and abdominal obesity (VAT ≥90 cm2 for men, ≥80 cm2 for women), who are non-smokers, drink little alcohol, have no serious health issues or recent substantial weight changes. Must be East Asian, Native Hawaiian/Pacific Islander or White ethnicity and fully vaccinated against COVID-19.

What is being tested?

The study is testing whether combining Intermittent Energy Restriction (IER) with the Mediterranean diet (MED) is more effective than daily energy restriction (DER) with MED in reducing belly fat and improving cancer-related markers over six months.

What are the potential side effects?

Potential side effects may include discomfort from fasting on IER days, possible nutritional deficiencies if not properly monitored, and general challenges associated with dietary restrictions such as hunger or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have taken antibiotics in the last 3 months.

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I am between 35 and 69 years old.

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I have lost or gained more than 20 pounds in the last 6 months.

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I drink less than 15 drinks a week if male, or 10 if female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes and am on insulin treatment.

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I am being treated for a thyroid condition with medication.

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I am a man currently taking medication to block male hormones.

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I cannot walk for up to an hour each day.

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I am currently taking anti-estrogen medications.

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I have had surgery to remove part of my intestine or an amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Abdominal magnetic resonance imaging (MRI) to measure visceral fat and liver fat

Dual-energy X-ray absorptiometry (DXA) scan for total adiposity

Secondary study objectives

Computed body mass index (BMI) (24 weeks post trial)

Computed body mass index (BMI) at end of trial.

DXA scan for total adiposity at week 48 (24 weeks post trial)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Mediterranean diet (MED) + daily energy restriction (DER) or MED/DERExperimental Treatment1 Intervention

The MED/DER group intervention will restrict 20% energy (25%, 45% and 30% distribution of protein, carbohydrate, and fat, respectively) continuously. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).

Group II: Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MEDExperimental Treatment1 Intervention

The IER+MED group intervention will be to restrict 70% energy (25%, 45% and 30% distribution of protein, carbohydrate, and fat, respectively) on 2 days and follow a MED diet (25%, 45%, 30%) and meet their estimated energy requirement (EER) for the other 5 days each week. This would be equivalent to an over-all 20% daily energy restriction. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Intermittent Energy Restriction combined with Mediterranean Diet (IER+MED) approach works by promoting a greater metabolic shift towards fat metabolism and preferentially reducing central obesity. IER involves periods of significant calorie reduction, which can enhance fat oxidation and improve insulin sensitivity. The Mediterranean Diet, rich in healthy fats, fiber, and antioxidants, supports overall metabolic health and reduces inflammation. This combination is particularly effective for abdominal obesity as it targets visceral fat, which is closely linked to metabolic diseases such as type 2 diabetes and cardiovascular disease. By reducing central obesity, these treatments can significantly improve health outcomes and reduce the risk of associated comorbidities.

Intermittent versus continuous energy restriction on weight loss and cardiometabolic outcomes: a systematic review and meta-analysis of randomized controlled trials.