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CompletedNCT00911885CANDOUpdated Mar 18, 2015

A Simple Dietary Message to Improve Dietary Quality for Metabolic Syndrome

An interventional study of Dietary Intervention in Metabolic Syndrome, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

Identifying a simple dietary recommendation for weight loss and metabolic health may demonstrate potential for a simple public health message to impact coronary heart disease (CHD) prevention and metabolic syndrome. In a randomized clinical trial, the investigators propose to compare the efficacy of two intervention approaches to dietary change for CHD prevention among persons with metabolic syndrome. The two approaches are 1) the AHA Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. The investigators hypothesize that a message promoting high fiber intake may be the simple message that has potential to produce broad impact.

Read the detailed description

The investigators will recruit 240 overweight and obese adults from a primary care setting who meet diagnostic criteria for metabolic syndrome. The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians. Assessments, including diet, anthropometrics, blood pressure, fasting blood glucose, glycosylated hemoglobin (HbA1c), blood lipids, insulin, inflammatory markers, medication use, depression, quality of life, and physical activity will be conducted at baseline and at 6-, and 12-months after randomization. A 3-month post-intensive intervention assessment will measure short-term changes in body weight, diet, and metabolic syndrome indicators.

02

Conditions studied

  • Metabolic Syndrome

Keywords

  • Weight
  • Diet
  • Lipids
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 240 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Meet diagnostic criteria for the metabolic syndrome;
  2. Interested in losing weight and have a BMI 30-40.22 BMI>40 kg/m2 indicates severe obesity and is associated with functional limitations that are likely to prevent participation in the study;
  3. Age 21 to 70 years old;
  4. Telephone in the home or easy access to one;
  5. Can provide informed consent;
  6. Physician's approval to participate in the study;
  7. Non-smoking status (given nicotine's effect on weight suppression, on HDL, and smoking cessation's effect weight gain); and
  8. Ability to speak and read English.

Exclusion criteria

Exclusion Criteria:

  1. Has clinically diagnosed diabetes, or a fasting blood sugar of ≥ 126 mg/dl;
  2. Had an acute coronary events within the previous 6 months;
  3. Pregnant or lactating;
  4. Women with polycystic ovary syndrome;133
  5. Plans to move out of the area within the 12-month study period;
  6. Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, active diverticulitis, renal disease);
  7. Has major depression or suicidality;
  8. Is following a low-carbohydrate, high-fat dietary regimen such as the Atkins' Diet.134 Is participating in any current weight loss program;
  9. Has had bariatric surgery or is currently using weight loss medication; and
  10. Has an eating disorder (anorexia nervosa, bulimia nervosa or binge eating). Patients on lipid-lowering medications will not be excluded, but should be on a stable dose for 6 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    High Fiber Diet

    A single dietary change condition that focuses exclusively on increasing fiber.

    Behavioral: Dietary Intervention

  • Active comparator
    AHA Diet

    The AHA Diet is the current recommendation for patients with the metabolic syndrome.

    Behavioral: Dietary Intervention

Interventions

  • BehavioralDietary Intervention

    The efficacy of the two dietary change interventions will be compared in a randomized controlled trial, with 120 patients per group. The two approaches are 1) the American Heart Association (AHA) Dietary Guidelines; and 2) a simple dietary change condition that focuses on increasing fiber. Patients in both conditions will receive intensive dietary instruction for 3 months, followed by a 9 month maintenance phase. Both conditions will receive dietary instructions via individual and group sessions led by registered dietitians.

06

What researchers measure

Primary outcomes

  1. Weight loss

    Time frame: 12 months

Secondary outcomes

  1. Changes in components of the metabolic syndrome, inflammatory markers, LDL cholesterol, insulin levels, HbA1c, and diet

    Time frame: 12 months

07

Study locations

1 site
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
08

References and documents

Publications

  • Olendzki BC, Ma Y, Schneider KL, Merriam P, Culver AL, Ockene IS, Pagoto S. A simple dietary message to improve dietary quality: Results from a pilot investigation. Nutrition. 2009 Jul-Aug;25(7-8):736-44. doi: 10.1016/j.nut.2009.01.009. Epub 2009 Apr 9. PubMed 19359142 ↗
  • Ma Y, Pagoto SL, Griffith JA, Merriam PA, Ockene IS, Hafner AR, Olendzki BC. A dietary quality comparison of popular weight-loss plans. J Am Diet Assoc. 2007 Oct;107(10):1786-91. doi: 10.1016/j.jada.2007.07.013. PubMed 17904938 ↗
  • Ma Y, Li W, Olendzki BC, Pagoto SL, Merriam PA, Chiriboga DE, Griffith JA, Bodenlos J, Wang Y, Ockene IS. Dietary quality 1 year after diagnosis of coronary heart disease. J Am Diet Assoc. 2008 Feb;108(2):240-6; discussion 246-7. doi: 10.1016/j.jada.2007.10.047. PubMed 18237571 ↗
  • Merriam PA, Ma Y, Olendzki BC, Schneider KL, Li W, Ockene IS, Pagoto SL. Design and methods for testing a simple dietary message to improve weight loss and dietary quality. BMC Med Res Methodol. 2009 Dec 30;9:87. doi: 10.1186/1471-2288-9-87. PubMed 20042092 ↗
  • Ma Y, Olendzki BC, Pagoto SL, Merriam PA, Ockene IS. What are patients actually eating: the dietary practices of cardiovascular disease patients. Curr Opin Cardiol. 2010 Sep;25(5):518-21. doi: 10.1097/HCO.0b013e32833cd538. PubMed 20625282 ↗
  • Wedick NM, Ma Y, Olendzki BC, Procter-Gray E, Cheng J, Kane KJ, Ockene IS, Pagoto SL, Land TG, Li W. Access to healthy food stores modifies effect of a dietary intervention. Am J Prev Med. 2015 Mar;48(3):309-17. doi: 10.1016/j.amepre.2014.08.020. Epub 2014 Oct 7. PubMed 25300734 ↗
  • Ma Y, Olendzki BC, Wang J, Persuitte GM, Li W, Fang H, Merriam PA, Wedick NM, Ockene IS, Culver AL, Schneider KL, Olendzki GF, Carmody J, Ge T, Zhang Z, Pagoto SL. Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial. Ann Intern Med. 2015 Feb 17;162(4):248-57. doi: 10.7326/M14-0611. PubMed 25686165 ↗
  • Wang J, Olendzki BC, Wedick NM, Persuitte GM, Culver AL, Li W, Merriam PA, Carmody J, Fang H, Zhang Z, Olendzki GF, Zheng L, Ma Y. Challenges in sodium intake reduction and meal consumption patterns among participants with metabolic syndrome in a dietary trial. Nutr J. 2013 Dec 18;12:163. doi: 10.1186/1475-2891-12-163. PubMed 24345027 ↗
  • Wang J, Persuitte G, Olendzki BC, Wedick NM, Zhang Z, Merriam PA, Fang H, Carmody J, Olendzki GF, Ma Y. Dietary magnesium intake improves insulin resistance among non-diabetic individuals with metabolic syndrome participating in a dietary trial. Nutrients. 2013 Sep 27;5(10):3910-9. doi: 10.3390/nu5103910. PubMed 24084051 ↗
  • Merriam PA, Persuitte G, Olendzki BC, Schneider K, Pagoto SL, Palken JL, Ockene IS, Ma Y. Dietary intervention targeting increased fiber consumption for metabolic syndrome. J Acad Nutr Diet. 2012 May;112(5):621-3. doi: 10.1016/j.jand.2012.01.024. Epub 2012 Apr 25. No abstract available. PubMed 22709766 ↗
  • Zhang L, Pagoto S, May C, Olendzki B, L Tucker K, Ruiz C, Cao Y, Ma Y. Effect of AHA dietary counselling on added sugar intake among participants with metabolic syndrome. Eur J Nutr. 2018 Apr;57(3):1073-1082. doi: 10.1007/s00394-017-1390-6. Epub 2017 Mar 28. PubMed 28353070 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00911885
Lead sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
Responsible party
Yunsheng Ma (Associate Professor, University of Massachusetts, University of Massachusetts, Worcester) — Principal investigator
First posted
Jun 3, 2009
Start date
Apr 2009
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 18, 2015

Study contacts

Yunsheng Ma, MD, Ph.D.
principal investigator · University of Massachusetts, Worcester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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