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Trial record 4 of 55 for:    cancer AND energy restriction

The Healthy Diet and Lifestyle Study (HDL)

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ClinicalTrials.gov Identifier: NCT03639350
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
The William and Ellen Melohn Endowed Research Fund
Information provided by (Responsible Party):
Carol J Boushey, University of Hawaii

Brief 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.

Condition or disease Intervention/treatment Phase
Visceral Fat Behavioral: IER+MED group Behavioral: DASH group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial. Participants will be randomized to either the IER+Med diet or the DASH diet for 12 weeks.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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 DASH diet group will be told they are on diet plan A. The research dietitians will know which diet plan each participant is on, however; all other clinic staff who assess outcomes measures will be blinded to each participant's diet group.
Primary Purpose: Prevention
Official Title: Obesity, Body Fat Distribution, and Cancer Risk in the Multiethnic Cohort Study
Actual Study Start Date : September 12, 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : June 15, 2018

Arm Intervention/treatment
Experimental: IER+MED group
The IER+MED group intervention will be to restrict 70% energy (34%, 33% and 33% distribution of protein, carbohydrate, and fat, respectively) on 2 days and follow the MED diet (25%, 45%, 30%) and meet their estimated energy requirement (EER) for the other 5 days each week. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
Behavioral: IER+MED group
Follow a Mediterranean diet 5 days per week and follow intermittent energy restriction 2 days per week.

Active Comparator: DASH group
The DASH group intervention will be to follow the DASH diet and meeting a distribution of macronutrients of 20% protein, 53% carbohydrate, and 30% fat and meet their EER. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
Behavioral: DASH group
Follow the distribution of macronutrients and food groups prescribed by the DASH diet 7 days per week.




Primary Outcome Measures :
  1. Change from Baseline Visceral adipose tissue (VAT) at 12 weeks [ Time Frame: Change from baseline VAT at 12 weeks ]
    VAT (cm2) measured at L4-L5 with Dual-energy X-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change from Baseline Blood Biomarkers at 12 weeks [ Time Frame: Change from baseline blood biomarkers at 12 weeks ]
    Insulin, Glucose, C-reactive protein (CRP), Interleukin-6 (IL-6), Adipokines (leptin and adiponectin), Insulin-like growth factor-1 (IGF-1), and Serum Lipids

  2. Change from Baseline DXA Subcutaneous Fat and Total Adiposity at 12 weeks [ Time Frame: Change from baseline subcutaneous fat and total adiposity at 12 weeks ]
    DXA subcutaneous fat and total adiposity

  3. Change from Baseline Lean Body Mass at 12 weeks [ Time Frame: Change from baseline lean body mass at 12 weeks ]
    DXA lean body mass

  4. Change from Baseline Resting Energy Expenditure (REE) at 12 weeks [ Time Frame: Change from baseline REE at 12 weeks ]
    REE measured with indirect calorimetry



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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 25-40
  • No serious health issues
  • Normal blood chemistry profile
  • VAT ≥90cm2 for men and ≥80cm2 for women
  • Japanese, Chinese, or Korean ancestry
  • Resident of Hawaii.

Exclusion Criteria:

  • Reported smoking tobacco products or marijuana in the past 2 years
  • Taking medication for Type 1 or Type 2 diabetes
  • Reported taking thyroid medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639350


Sponsors and Collaborators
University of Hawaii
The William and Ellen Melohn Endowed Research Fund
Investigators
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Principal Investigator: Loic Le Marchand, MD, PhD University of Hawaii Cancer Research Center
Study Chair: Carol J Boushey, PhD, RDN University of Hawaii Cancer Research Center
Study Chair: Unhee Lim, PhD University of Hawaii Cancer Research Center

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carol J Boushey, Associate Research Professor, University of Hawaii
ClinicalTrials.gov Identifier: NCT03639350     History of Changes
Other Study ID Numbers: 12619302B
4502286 ( Other Identifier: University of Hawaii Cancer Center )
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carol J Boushey, University of Hawaii:
intermittent energy restriction
Randomized Controlled Trial
Adiposity