Weight Loss Effects on Heart and Blood Vessel Function in Obesity

NCT00782262 | Unknown Phase 2 DMC

• 1 other identifier: 050226
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Study Arms (3)

Group 1 (n=20)

OTHER

BP \< 140/90, no diabetes mellitus and fasting glucose \< 5.5

Dietary Supplement: KicStart™

Group 2 (n=20)

OTHER

BP \> 140/100, no diabetes mellitus and fasting glucose \< 5.5

Dietary Supplement: KicStart™

Group 3 (n=20)

OTHER

BP \<140/100, no diabetes mellitus, fasting glucose 5.5 - 6.9

Dietary Supplement: KicStart™

Interventions

KicStart™ DIETARY_SUPPLEMENT

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); Group 2 (n=20); Group 3 (n=20)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Adelaide: lead
• Royal Adelaide Hospital: collaborator

Study Sites (1)

University of Adelaide, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cynthia Piantadosi, PhD

CONTACT

61 8 82222473; cynthia.piantadosi@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 31, 2008
• Study Start: April 1, 2005
• Primary Completion: January 1, 2009
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

AU (1)