Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Weight Loss Effects on Heart and Blood Vessel Function in Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Adelaide.
Recruitment status was  Recruiting
Royal Adelaide Hospital
Information provided by:
University of Adelaide Identifier:
First received: October 28, 2008
Last updated: October 29, 2008
Last verified: October 2008

October 28, 2008
October 29, 2008
April 2005
January 2009   (final data collection date for primary outcome measure)
This will be the first analysis of the impact of rapid aggressive weight loss in obese individuals on both short and long-term cardiovascular indices. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00782262 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Weight Loss Effects on Heart and Blood Vessel Function in Obesity
Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men

Obesity is a growing epidemic and is associated with an increased risk of heart attack and stroke. The investigators know that obesity leads to abnormalities in how the blood vessels and the heart function and that these abnormalities are an important cause of this increased risk in obese individuals. While improvements in these abnormalities have been reported with marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is not clear that these abnormalities can be substantially reversed with standard dietary interventions. Additional information is needed regarding the degree of weight loss required, the time course of these improvements, nor the mechanisms. All of these have major implications for the potential role of weight loss in the management of these patients.

The investigators will assess the effects of dietary induced weight loss in both the short and long term on the function of blood vessels and the heart, and the relationship of any changes with markers of inflammation that are present in obesity.

By understanding the factors that are important in reversing these abnormalities in obesity the investigators will be better to identify and reduce heart attack and stroke in obese individuals in the future.

Not Provided
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Dietary Supplement: KicStart™
KicStart™ is a nutritionally complete, but lower energy formulated liquid meal. Two sachets of KicStart™ (one for breakfast and one for lunch) provides 450 cal of energy per day, 0.8 grams per kilogram ideal body weight of high quality protein, and the recommended daily allowances (RDI) of minerals, vitamins, trace elements, omega 3 and 6 essential fatty acids. The Kicstart is supplemented with some salads, carbohydrate free vegetables and a small piece of meat fish or chicken each day in order to achieve a total energy intake of approximately 850 kcals/day.
  • Group 1 (n=20)
    BP < 140/90, no diabetes mellitus and fasting glucose < 5.5
    Intervention: Dietary Supplement: KicStart™
  • Group 2 (n=20)
    BP > 140/100, no diabetes mellitus and fasting glucose < 5.5
    Intervention: Dietary Supplement: KicStart™
  • Group 3 (n=20)
    BP <140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9
    Intervention: Dietary Supplement: KicStart™
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese Caucasian men age 18-65 years, who are non smokers, and consuming 2 or fewer standard alcoholic drinks per day (on average over the past 5 years) will be recruited.
  • Obesity, for the purposes of this study, is defined by a BMI > 30 and a waist circumference > 102 cm.
  • Caucasian men only are enrolled because the cut-off points for the definition of obesity vary significantly by race.

Exclusion Criteria:

  • Men are excluded if they have any previously diagnoses or symptomatic atherosclerotic disease, or are taking any cardiovascular medication.
  • Men with known gallstones, history of gout, or any contraindication to MRI are also excluded.
18 Years to 65 Years
Contact: Cynthia Piantadosi, PhD 61 8 82222473
Dr Cynthia Piantadosi, University of Adelaide and Royal Adelaide Hospital
University of Adelaide
Royal Adelaide Hospital
Not Provided
University of Adelaide
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP