A Phase 2/3 interventional study of KicStart™ in Obesity, sponsored by University of Adelaide. Status unknown at 1 site in Australia. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-31.
Sponsored by University of Adelaide · Phase 2/3, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Adelaide is the lead sponsor of 42 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BP \< 140/90, no diabetes mellitus and fasting glucose \< 5.5
Dietary Supplement: KicStart™
BP \> 140/100, no diabetes mellitus and fasting glucose \< 5.5
Dietary Supplement: KicStart™
BP \<140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9
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.
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
This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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University of Adelaide