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Long-term health effects of high and low carbohydrate diets in obese subjects with the metabolic syndrome

Long-term health effects of high and low carbohydrate, weight loss diets in obese subjects with the metabolic syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000203550
Enrollment
120
Registered
2006-05-29
Start date
2006-04-03
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obesity is a major health problem, which contributes to significant morbidity and mortality in Australia. Energy restriction and exercise are commonly advocated as lifestyle approaches for the modification of cardiovascular disease risk factors such as obesity, hyperlipidemia, impaired glucose tolerance, and insulin resistance. In response to the increasing concerns about the rising level of obesity, there has been a multitude of “fad” diets developed outside the medical and nutritional recommendations for healthy eating and with this an increased popularity of diets very low in carbohydrates. However, due to the scant scientific evidence available for the long-term efficacy and safety of these diets, and their impact on risk factors for cardiovascular disease, cancer, renal function, bone health, psychosocial function and the capacity to undertake concurrent physical activity, there is a lack of evidenced-based public health recommendations and policy regarding these dietary patterns. This study will provide scientific evidence to validate optimum dietary recommendations for weight loss that can be used by health professionals who have a strong need for a rational basis for their advice to counsel obese patients.

Interventions

participants will be randomised for the 52 week intervention duration to either; 1. Low carbohydrate diet:35% protein, 61% fat (20% saturated fat) 4% carbohydrate 2. High carbohydrate,low fat diet:18% protein, 27% fat (<8% saturated fat) 55% carbohydrate

Sponsors

national health & medical research council of Australia
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

High waist circumferenceat least one cardiovascular risk factor.

Exclusion criteria

Have proteinuria, a malignancy, or a history of metabolic disease such as liver, kidney, cardiovascular, respiratory or gastrointestinal disease, diabetes (fasting blood glucose or are pregnantUncontrolled hypertension (resting recumbent BP >160/110 mmHg).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026