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Weight Loss Effects on Heart and Blood Vessel Function in Obesity

NCT ID: NCT00782262

Last Updated: 2008-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 (n=20)

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

Group Type OTHER

KicStart™

Intervention Type 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 2 (n=20)

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

Group Type OTHER

KicStart™

Intervention Type 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 3 (n=20)

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

Group Type OTHER

KicStart™

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Adelaide Hospital

OTHER

Sponsor Role collaborator

University of Adelaide

OTHER

Sponsor Role lead

Responsible Party

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University of Adelaide and Royal Adelaide Hospital

Locations

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University of Adelaide, Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Cynthia Piantadosi, PhD

Role: CONTACT

Phone: 61 8 82222473

Email: [email protected]

Facility Contacts

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Gary Wittert, MD, MB Bch, FRACP

Role: primary

Other Identifiers

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050226

Identifier Type: -

Identifier Source: org_study_id