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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

(HDLS2) Trial Summary

This trial will compare the effect of two diets on reducing abdominal fat and liver fat in obese people. One diet is a Mediterranean diet with intermittent energy restriction, and the other is a daily energy-restricted diet. The trial will recruit 312 people and randomize them to the two diets. The primary research question is whether the intermittent energy restriction diet will be superior to the daily energy restriction diet in reducing abdominal and liver fat.

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.Check my eligibility

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.See study design

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.

(HDLS2) Trial 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.

(HDLS2) Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

(HDLS2) 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,616 Total Patients Enrolled

University of Hawaii Cancer Research CenterOTHER

9 Previous Clinical Trials

1,678 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,666 Previous Clinical Trials

40,925,769 Total Patients Enrolled

Media Library

IER+MED (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05132686 — N/A

Abdominal Obesity Research Study Groups: Mediterranean diet (MED) + daily energy restriction (DER) or MED/DER, Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED

Abdominal Obesity Clinical Trial 2023: IER+MED Highlights & Side Effects. Trial Name: NCT05132686 — N/A

IER+MED (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132686 — N/A

Abdominal Obesity Patient Testimony for trial: Trial Name: NCT05132686 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being considered for enrollment in this clinical trial?

"This clinical trial is recruiting individuals who have attained the age of majority and are below the age of 70."

Answered by AI

How many participants are registering for the trial?

"Affirmative. The data on clinicaltrials.gov affirms that this research is currently recruiting participants, with the first post dated January 20th 2022 and last updated April 11th 2022. Currently, 260 people are being recruited from one institution."

Answered by AI

Are researchers still accepting participants into this research program?

"Affirmative, according to the information available on clinicaltrials.gov this medical trial is still accepting participants. It was first announced on January 20th 2022 and its last update happened April 11th 2022. 260 patients are required for the single-site study."

Answered by AI

What is the criteria for persons to qualify as enrollees in this research?

"This investigation is admitting 260 individuals with intra-abdominal fat who are aged between 35 and 69. Eligibility criteria includes but is not limited to: Age 35-69 years old, BMI 25-40 kg/m2, Non-smoking status, Absence of severe medical issues, Vaccination against COVID-19 completed, Standardised blood chemistry values, VAT area at L4/L5 ≥90 cm2 for male participants and ≥80 cm2 for female participants; East Asian ethnicity or White ancestry; Resident in Honolulu County; Low alcohol consumption (≤15 drinks per week for men and ≤10 drinks per"

Answered by AI

What objectives does this scientific research endeavor to fulfill?

"This clinical trial, which will be monitored until Week 24, has the primary goal of measuring total adiposity via Dual-energy X-ray absorptiometry (DXA) scan. Secondary objectives include assessing body weight at week 48 post trial to evaluate if the IER+MED diet plan is more effective than MED/DER in sustaining long term weight loss; determining BMI levels upon completion of the study to determine if IER+MED can reduce bodyweight better than MED/DER; and taking waist & hip circumferences measurements 24 weeks after the end of the trial to check whether or not IER+MED improves longterm weight"

Answered by AI

Who else is applying?

What state do they live in?

Louisiana

Virginia

Indiana

Other

How old are they?

18 - 65

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

University of Hawaii Cancer Center

How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried many ways to lose weight. I am interested in your study and can travel.

PatientReceived 1 prior treatment

I've been trying for 20+ years to lose weight...fad diets, exercise, lifestyle changes, doctors, weight loss programs, pills, etc. Some methods worked better than others but I have never come close to achieving my goal weight. While I have been able to lose over 100lbs over a 4 year period, I am still struggling, and am, in fact, gaining again. The excess weight is affecting my daily life like it never has before and I need help.

PatientReceived 2+ prior treatments