The Healthy Diet and Lifestyle Study

Summary

This pilot study aims to develop a study design to test the difference between a fasting diet and a heart healthy diet, assess participants' adherence to the study design, and to test whether either diet helps to reduce fat wrapped around the organs in the stomach area and total body fat in East Asian American adults. 70 men and women residents of Oahu Hawai'i, aged 35-55, who are overweight or obese and have moderate to high amounts of fat around organs in the stomach area, of Japanese, Chinese, or Korean ancestry, will be equally distributed to either the fasting diet or the heart healthy diet and asked to follow this diet for the 12-week study. Each diet has set requirements for energy, protein, carbohydrates, and fat. The fasting diet has two days of fasting, where participants will be asked to follow a low carbohydrate- low energy diet, and five days of a balanced diet without any energy restriction (the Mediterranean diet). The other group will follow a heart healthy diet (Dietary Approaches to Stop Hypertension diet) for all seven days without any energy restriction. Both groups will be asked to follow a moderate exercise program (one hour of walking five days a week). Dietitians will provide information on diet and exercise requirements to the participants at the start of the study. Dietitians will contact the participants seven times, primarily by phone, to offer support and to check if the participants are following prescribed diet and exercise plans. Participants will use a mobile phone app to take images of all foods and drinks for four days at the beginning, middle and end of the 12-week study. Body measurements, including measurements of body fat, will be taken at the beginning and end of the study by trained clinic staff. The analysis of the food images, participants' self-reported compliance to diet and exercise plans, and body measurements will be used to determine if the study design and participant compliance to the study are successful, and to assess which diet is better at reducing total body fat and fat around the organs in the stomach region.

Conditions

• Visceral Fat

Interventions

BEHAVIORAL

IER+MED group

Follow a Mediterranean diet 5 days per week and follow intermittent energy restriction 2 days per week.

BEHAVIORAL

DASH group

Follow the distribution of macronutrients and food groups prescribed by the DASH diet 7 days per week.

Sponsors & Collaborators

• The William and Ellen Melohn Endowed Research Fund

  collaborator UNKNOWN

• University of Hawaii

  lead OTHER

Principal Investigators

• Loic Le Marchand, MD, PhD · University of Hawaii Cancer Research Center

• Carol J Boushey, PhD, RDN · University of Hawaii Cancer Research Center

• Unhee Lim, PhD · University of Hawaii Cancer Research Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-12

Primary Completion

2018-01-15

Completion

2018-06-15