Clinical trial · Interventional
The Healthy Diet and Lifestyle Study
Obesity, Body Fat Distribution, and Cancer Risk in the Multiethnic Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Visceral Fat | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DASH group | Behavioral | — | UNRESOLVED |
| IER+MED group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IER+MED group
- description
- 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).
- interventionNames
- Behavioral: IER+MED group
- type
- ACTIVE_COMPARATOR
- label
- DASH group
- description
- 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).
- interventionNames
- Behavioral: DASH group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDHarvie 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
- BACKGROUNDHarvie 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
- DERIVEDO'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
- DERIVEDPanizza 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