The Healthy Diet and Lifestyle Study

NCT03639350 | Completed DMC

• 2 other identifiers: 12619302B4502286
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Visceral Fat

Keywords

intermittent energy restriction; Randomized Controlled Trial; Adiposity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Visceral adipose tissue (VAT) at 12 weeks

  VAT (cm2) measured at L4-L5 with Dual-energy X-ray absorptiometry (DXA)

  Change from baseline VAT at 12 weeks

Secondary Outcomes (4)

• Change from Baseline Blood Biomarkers at 12 weeks

  Change from baseline blood biomarkers at 12 weeks

• Change from Baseline DXA Subcutaneous Fat and Total Adiposity at 12 weeks

  Change from baseline subcutaneous fat and total adiposity at 12 weeks

• Change from Baseline Lean Body Mass at 12 weeks

  Change from baseline lean body mass at 12 weeks

• Change from Baseline Resting Energy Expenditure (REE) at 12 weeks

  Change from baseline REE at 12 weeks

Study Arms (2)

IER+MED group

EXPERIMENTAL

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

DASH group

ACTIVE COMPARATOR

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

Interventions

IER+MED group BEHAVIORAL

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

IER+MED group

DASH group BEHAVIORAL

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

DASH group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Hawaii: lead
• The William and Ellen Melohn Endowed Research Fund: collaborator

Related Publications (4)

• Harvie M, Wright C, Pegington M, McMullan D, Mitchell E, Martin B, Cutler RG, Evans G, Whiteside S, Maudsley S, Camandola S, Wang R, Carlson OD, Egan JM, Mattson MP, Howell A. The effect of intermittent energy and carbohydrate restriction v. daily energy restriction on weight loss and metabolic disease risk markers in overweight women. Br J Nutr. 2013 Oct;110(8):1534-47. doi: 10.1017/S0007114513000792. Epub 2013 Apr 16.

  PMID: 23591120 BACKGROUND

• Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.

  PMID: 20921964 BACKGROUND

• 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 DERIVED

• Panizza CE, Lim U, Yonemori KM, Cassel KD, Wilkens LR, Harvie MN, Maskarinec G, Delp EJ, Lampe JW, Shepherd JA, Le Marchand L, Boushey CJ. Effects of Intermittent Energy Restriction Combined with a Mediterranean Diet on Reducing Visceral Adiposity: A Randomized Active Comparator Pilot Study. Nutrients. 2019 Jun 20;11(6):1386. doi: 10.3390/nu11061386.

  PMID: 31226790 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

• Carol J Boushey, PhD, RDN

  University of Hawaii Cancer Research Center

  STUDY CHAIR

• Unhee Lim, PhD

  University of Hawaii Cancer Research Center

  STUDY CHAIR

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 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Model Details: Randomized controlled trial. Participants will be randomized to either the IER+Med diet or the DASH diet for 12 weeks.

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: August 21, 2018
• Study Start: September 12, 2016
• Primary Completion: January 15, 2018
• Study Completion: June 15, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share