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| Sponsors and Collaborators: |
University of Adelaide Royal Adelaide Hospital |
|---|---|
| Information provided by: | University of Adelaide |
| ClinicalTrials.gov Identifier: | NCT00782262 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Dietary Supplement: KicStart™ |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2005 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1 (n=20)
BP < 140/90, no diabetes mellitus and fasting glucose < 5.5
|
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 2 (n=20)
BP > 140/100, no diabetes mellitus and fasting glucose < 5.5
|
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 3 (n=20)
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cynthia Piantadosi, PhD | 61 8 82222473 | cynthia.piantadosi@adelaide.edu.au |
| Australia, South Australia | |
| University of Adelaide, Royal Adelaide Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Gary Wittert, MD, MB Bch, FRACP +61 8 8222.5502 gary.wittert@adelaide.edu.au | |
| Principal Investigator: Cynthia Piantadosi, PhD | |
More Information
| Responsible Party: | University of Adelaide and Royal Adelaide Hospital ( Dr Cynthia Piantadosi ) |
| Study ID Numbers: | 050226 |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00782262 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Body Weight Signs and Symptoms Obesity Vitamins Weight Loss Body Weight Changes |
Nutrition Disorders Trace Elements Overweight Overnutrition Micronutrients |
|
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |
