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Dietary approaches for treatment of the metabolic syndrome in overweight and obese women.

A randomised, controlled dietary intervention to evaluate the effect of a high protein diet compared with a high carbohydrate, high fibre diet on individual components of the metabolic syndrome and markers of cardiovascular disease risk in overweight and obese women.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000852055
Enrollment
80
Registered
2010-10-13
Start date
2008-05-26
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

The metabolic syndrome is defined by a number of associated risk factors that cluster together in individuals increasing their risk of diabetes and heart disease. These factors include insulin resistance, abdominal obesity, high blood pressure, dyslipidaemia and raised blood sugar. The likelihood of dying of heart disease is increased three-fold in people with metabolic syndrome (diagnosed as having at least three risk factors). There is limited reporting on the prevalence of the metabolic syndrome in New Zealand, but reports suggest it could be more than 20% in adult New Zealanders with more than double the prevalence in adult Maori and Pacific Islanders. Correspondingly an estimated 7% of New Zealand adults have suffered a non-fatal heart disease event and the prevalence of diagnosed diabetes in New Zealand is estimated to be 4% in the general New Zealand population and as high as 12% in Maori and Pacific Islanders. These are likely to be underestimates and the prevalence is further increased when including estimates of undiagnosed cases. Clearly, determining effective strategies for managing metabolic syndrome risk factors is warranted. A number of lifestyle interventions indicate that clinically important improvements in insulin sensitivity, body weight, hypertension and blood fats are achievable. However we currently have little indication of which dietary modifications will achieve the greatest change. Both dietary fibre and dietary protein have shown promise in numerous studies but results have been inconsistent and many questions remain unanswered. This study attempts determine the ways and extent to which metabolic syndrome risk factors can be influenced by high fibre and high protein diets.

Interventions

Participants were randomised to one of two diets for eight weeks: 1. A hypocaloric (approximately 5500kJ/day) high protein diet (30% protein, 30% fat, 40% carbohydrate, ~25g total dietary fibre per day).

Sponsors

Professor Jim Mann
Lead SponsorIndividual

Study design

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

Eligibility

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

Inclusion criteria

Overweight (body mass index (BMI)> 27kg/m^2). Weight stable over last 3 months. Prepared to undergo dietary intervention and eat substantial amounts of dietary fibre including wholegrains, legumes and pulses.

Exclusion criteria

No diabetes, psychiatric illness, drug or alcohol dependence that would affect ability to adhere to the dietary guidelines. No history of an eating disorder or renal or hepatic failure. Not on lipid lowering medications or medications known to affect metabolism. Not pregnant, lactating or planning to become pregnant in the next 8 weeks.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026