Effects of Intermittent Energy Restriction on Intra-Abdominal Fat and the Gut Microbiome: A Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 69
Healthy Volunteers: t
View:

• 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

Locations
United States
Hawaii
University of Hawaii Cancer Center
RECRUITING
Honolulu
Contact Information
Primary
Carol J Boushey, PhD, RDN
cjboushey@cc.hawaii.edu
765-404-8366
Backup
Loic Le Marchand, MD, PhD
loic@cc.hawaii.edu
808-564-5899
Time Frame
Start Date: 2022-01-20
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 260
Treatments
Experimental: Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
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).
Experimental: Mediterranean diet (MED) + daily energy restriction (DER) or MED/DER
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).
Sponsors
Collaborators: University of Hawaii Cancer Research Center, National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: University of Hawaii

This content was sourced from clinicaltrials.gov