The Healthy Diet and Lifestyle Study II

NCT05132686 | Recruiting DMC

• 2 other identifiers: LEMARCHAND-2021-21R01CA258179-01A1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Intermittent energy restriction (IER) may have important advantages over daily energy restriction (DER) in producing sustained weight loss and reducing cancer risk. IER is already being promoted with limited evidence, thus, additional evidence is urgently needed from rigorously conducted clinical trials. IER has been proposed to invoke a greater metabolic shift to fat metabolism than DER and preferentially reduce central obesity. The Investigators adapted the IER and the Mediterranean diet (MED) approach which have been recommended as a healthy weight-loss diet in the management of non-alcoholic fatty liver disease, for an ethnically diverse population. The effectiveness was compared to an active comparator (DASH diet) in reducing overall and visceral adiposity in a randomized trial among 60 middle-aged adults with visceral obesity. This 12-week pilot demonstrated the feasibility and safety of IER and the culturally-adapted MED \[NCT03639350\]. The six-month randomized trial will demonstrate the superiority of IER over DER in reducing fat and total fat mass, and in improving cancer-related biomarkers and gut microbiome functions. This longer trial, to confirm safety and superiority of IER over DER in reducing VAT and liver fat will expand our understanding of adherence to IER and its effect on the gut microbiome as a possible mediator of systemic inflammation. The Investigators will conduct a 24-week randomized trial of IER+MED vs. MED/DER among 260 middle-aged adults of East-Asian, Native Hawaiian and other Pacific Islanders or White ethnicity with high VAT. The primary research question is whether a diet plan combining IER and the MED dietary pattern will be superior to MED/DER in reducing abdominal MRI-measured visceral and liver fat and dual-energy X-ray absorptiometry (DXA) measured total adiposity. The Healthy Diet and Lifestyle Study II (HDLS2) will recruit 312 men and women from the general population with VAT at or above the population-median (men: ≥90 cm2; women ≥80 cm2) and randomize them to the IER+MED or MED/DER diet (156 per group). The IER+MED group will follow IER for two consecutive days (70% energy restriction) and total energy MED diet for the other five days of the week, reaching an overall 20% energy restriction. The MED/DER group will be prescribed a 20% daily energy restriction. With an expected attrition rate of \~16% (10% in Pilot), the investigators expect 130 participants per group to complete the study.

Conditions

Intra-Abdominal Fat

Keywords

Visceral Adipose Tissue, Visceral Fat; Intermittent energy restriction; Randomized Controlled Trial; Adiposity

Outcome Measures

Primary Outcomes (2)

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

  To investigate whether a diet plan combining intermittent energy restriction (IER) and a Mediterranean diet (MED) dietary pattern (IER+MED) will be superior to a MED diet and daily energy restriction (DER) (MED/DER) in reducing abdominal MRI-measured visceral and liver fat.

  Week 24

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

  To investigate whether the diet plan IER+MED will be superior to MED/DER in reducing DXA-measured total adiposity.

  Week 24

Secondary Outcomes (9)

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

  Week 48

• Measured body weight at end of trial

  Week 24

• Measured body weight at week 48 (24 weeks post trial).

  Week 48

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

  Week 24

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

  Week 48

Study Arms (2)

Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED

EXPERIMENTAL

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).

Behavioral: IER+MED

Mediterranean diet (MED) + daily energy restriction (DER) or MED/DER

EXPERIMENTAL

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).

Behavioral: MED/DER

Interventions

IER+MED BEHAVIORAL

Over a 6 month period follow a euenergetic Mediterranean diet 5 days per week and a 20% energy restriction over 2 contiguous days as a 70% energy restriction using the same macronutrient distribution of 45% carbohydrate, 25% energy from protein, and 30% energy from fat. For each participant a tailored diet plan is created based on sex, weight, height, and age. Complete a 1 hour walk five days per week.

Also known as: The Healthy Diet and Lifestyle Study II (HDLS2)

Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED

MED/DER BEHAVIORAL

Over a 6 month period follow a Mediterranean diet 7 days per week with a 20% energy restriction 7 days a week using the macronutrient distribution of 45% carbohydrate, 25% energy from protein, and 30% energy from fat. For each participant a tailored diet plan is created based on sex, weight, height, and age. Complete a 1 hour walk five days per week.

Also known as: The Healthy Diet and Lifestyle Study II (HDLS2)

Mediterranean diet (MED) + daily energy restriction (DER) or MED/DER

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-69 years old
• BMI between 25-40 kg/m2
• Currently non-smoking
• No serious health issues
• Fully vaccinated for COVID-19
• Normal blood chemistry profile
• East Asian (Chinese, Japanese, Korean), Filipino, Native Hawaiian/other Pacific Islander or white/European ancestry
• Non-drinkers / low habitual drinkers, i.e., men ≤15 drinks per week, women ≤10 drinks per week
• Volunteers living on the island of Oahu
• For peri-menopausal women, the investigators will require that they had their last period at least 1 year before baseline)
• DXA VAT ≥90 cm2 for men and ≥80 cm2 for women
• Able to read, speak, and write in English

You may not qualify if:

• Pregnancy
• Contraindication to MR imaging (e.g. pacemaker, claustrophobia, metal implants)
• Previous surgery to remove any part of the small intestine, colon or rectum (e.g.
• ileostomy or colectomy) or an amputation of a leg or arm.
• For women, taking any anti-estrogen medications (e.g tamoxifen, Nolvadex, Istubal, Valodex)
• For men, taking any anti-androgen medications (e.g., Eulexin (flutamide); Anandron or Nilandron (nilutamide); Casodex (bicalutamide); Proscar or Propecia (finasteride); Avodart (dutasteride); or bexlosteride, izonsteride, turosteride, episteride).
• Diagnosis of Type 1 diabetes or Type 2 diabetes and taking insulin for treatment
• Diagnosis of thyroid conditions under treatment with hormones or medications.
• Serious health issues such as dialysis, organ transplant, celiac disease, Crohn's disease, chronic liver disease, active case of hepatitis B or C, chronic kidney disease, or any condition that, in the opinion of the investigator, is a contraindication to participation.
• Previous problem with fasting blood collection
• Cannot exercise (walk) for up to 1hr/day
• Deferral Criteria :
• Volunteers with the following conditions will be called back after the specified duration:
• Treatments in past 6 months: chemotherapy or radiation of abdomen/pelvis; corticosteroid hormones; prescription weight loss drugs; estrogen/androgen receptor blockers
• Substantial weight change (\>20lbs) in past 6 months

Sponsors & Collaborators

• University of Hawaii: lead
• National Institutes of Health (NIH): collaborator
• University of Hawaii Cancer Research Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

RECRUITING

Related Publications (3)

• O'Reilly H, Panizza CE, Lim U, Yonemori KM, Wilkens LR, Shvetsov YB, Harvie MN, Shepherd J, Zhu FM, Le Marchand L, Boushey CJ, Cassel KD. Utility of self-rated adherence for monitoring dietary and physical activity compliance and assessment of participant feedback of the Healthy Diet and Lifestyle Study pilot. Pilot Feasibility Stud. 2021 Feb 11;7(1):48. doi: 10.1186/s40814-021-00786-3.

  PMID: 33573693 RESULT

• Panizza CE, Wong MC, Kelly N, Liu YE, Shvetsov YB, Lowe DA, Weiss EJ, Heymsfield SB, Kennedy S, Boushey CJ, Maskarinec G, Shepherd JA. Diet Quality and Visceral Adiposity among a Multiethnic Population of Young, Middle, and Older Aged Adults. Curr Dev Nutr. 2020 May 26;4(6):nzaa090. doi: 10.1093/cdn/nzaa090. eCollection 2020 Jun.

  PMID: 33959689 RESULT

• Lewis MY, Yonemori K, Ross A, Wilkens LR, Shepherd J, Cassel K, Stenger A, Rettenmeier C, Lim U, Boushey C, Le Marchand L. Effect of Intermittent vs. Continuous Energy Restriction on Visceral Fat: Protocol for The Healthy Diet and Lifestyle Study 2 (HDLS2). Nutrients. 2024 May 14;16(10):1478. doi: 10.3390/nu16101478.

  PMID: 38794715 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Loic Le Marchand, MD, PhD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol J Boushey, PhD, RDN

CONTACT

765-404-8366; cjboushey@cc.hawaii.edu

Loic Le Marchand, MD, PhD

CONTACT

808-564-5899; loic@cc.hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be provided with healthful dietary information but will not be told what diets their diet plans are based on. Participants in the IER+MED diet group will be told they are on diet plan 1 and participants in the MED/DER diet group will be told they are on diet plan A. The dietitians will know which diet plan each participant is on, however; all other clinic staff who assess outcome measures will be blinded to each participant's diet group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trail. Participants will be randomized to either intermittent energy restriction (IER) and Mediterranean diet (MED) / IER+MED or the daily energy restriction (DER) and the Mediterranean diet / (MED/DER).

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: November 24, 2021
• Study Start: January 20, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD and supporting information will become available at least 2 years after the study ends and the 3 designated papers are submitted.
• Access Criteria: Qualified researchers who have received IRB approval would be eligible to receive data. At least one original member of the Healthy Diet and Life Style Study HDLS2 would need to be included as a co-author. The Investigators will share experimental and behavioral data associated with the study participants by depositing these data with the University of Hawaii Biostatistics Shared Resource. To prepare the materials, the usual fees will be implemented. Information can be accessed at: The University of Hawaii Cancer Center, Biostatistics Shared Resource.

Locations

US (1)