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
Recruitment status was Recruiting
Sponsor:
University of Adelaide
Collaborator:
Royal Adelaide Hospital
Information provided by:
University of Adelaide
ClinicalTrials.gov Identifier:
NCT00782262
First received: October 28, 2008
Last updated: October 29, 2008
Last verified: October 2008
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men |
Resource links provided by NLM:
Further study details as provided by University of Adelaide:
Primary Outcome Measures:
- 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 ]
| 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 |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782262
Contacts
| Contact: Cynthia Piantadosi, PhD | 61 8 82222473 | cynthia.piantadosi@adelaide.edu.au |
Locations
| 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 | |
Sponsors and Collaborators
University of Adelaide
Royal Adelaide Hospital
More Information
No publications provided
| Responsible Party: | Dr Cynthia Piantadosi, University of Adelaide and Royal Adelaide Hospital |
| ClinicalTrials.gov Identifier: | NCT00782262 History of Changes |
| Other Study ID Numbers: | 050226 |
| Study First Received: | October 28, 2008 |
| Last Updated: | October 29, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on June 18, 2013