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Differences between energy-restricted high-protein versus high-carbohydrate, low-fat diet in weight loss and maintenance

A randomized trial of energy-restricted high-protein versus high-carbohydrate, low-fat diet in morbid obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12558934
Enrollment
88
Registered
2016-05-16
Start date
2007-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Class II and III obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

The treatment was divided into two stages: Stage One (inpatient treatment
3 weeks)
Stage Two (outpatient treatment
48 weeks). Participants started the assigned diet on the second inpatient day, and continued it during the whole Stage Two. They were admitted in consecutive blocks of 8, all following the same diet

Sponsors

Regional Agency for Health and Social Care, Regione Emilia-Romagna (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age range 18-65 years 2. Body mass index (BMI) = 40.0 kg/m2 or between 35 and 39.9 with at least one weight loss-responsive comorbidity (e.g., type 2 diabetes, cardiovascular diseases, sleep apnea, severe joint disease, two or more risk factors defined by the Adult Treatment Panel III)

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactating 2. Took medications affecting body weight 3. Medical comorbidities associated with weight loss or had severe psychiatric disorders (e.g., acute psychotic states, bipolar disorder, bulimia nervosa)

Design outcomes

Primary

MeasureTime frame
Percent weight loss at study end (1 year)

Secondary

MeasureTime frame
The secondary outcomes were assessed at baseline, after 3 weeks, after 27 weeks and after 1 year. 1. Attrition rates 2. Cardiovascular risk factors and psychological profile, measured using: 2.1. The Body Uneasiness Test-A 2.2. The Binge Eating test 2.3. Beck Depression Inventory 2.4. Beck Anxiety Inventory

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026