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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
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 belowSelect...
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:Select...
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
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 moreTrial 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).
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.
Intermittent versus continuous energy restriction on weight loss and cardiometabolic outcomes: a systematic review and meta-analysis of randomized controlled trials.
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,789 Previous Clinical Trials
8,137,884 Total Patients Enrolled
University of Hawaii Cancer Research CenterOTHER
10 Previous Clinical Trials
1,820 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,010,517 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes and am on insulin treatment.I have taken antibiotics in the last 3 months.Your body mass index (BMI) is between 25 and 40, which means you may be overweight or obese.I am between 35 and 69 years old.I cannot walk for up to an hour each day.I am a man currently taking medication to block male hormones.I am being treated for a thyroid condition with medication.I have lost or gained more than 20 pounds in the last 6 months.I am currently taking anti-estrogen medications.I have had surgery to remove part of my intestine or an amputation.I am a woman who has not had a menstrual period for at least 1 year.I do not have any serious health problems.I drink less than 15 drinks a week if male, or 10 if female.You are of East Asian, Native Hawaiian/other Pacific Islander or white descent.
Research Study Groups:
This trial has the following groups:- Group 1: Mediterranean diet (MED) + daily energy restriction (DER) or MED/DER
- Group 2: Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Abdominal Obesity Patient Testimony for trial: Trial Name: NCT05132686 — N/A
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