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CompletedNCT00862953LOWERUpdated Apr 18, 2024

Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study

An interventional study of Normal protein energy-restricted and High protein energy-restricted in Obesity, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
317
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Read the detailed description

Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

02

Conditions studied

  • Obesity

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Keywords

  • low carbohydrate
  • high protein diet
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 317 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Obesity with BMI > 27 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Recent loss of body weight (>10%)
  • Underlying malignancy, HIV infection, psychiatric disease
  • Pregnancy or breast feeding
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
317 participants (actual)

Study arms

  • Active comparator
    Normal protein normal carbohydrate

    Normal protein normal carbohydrate calory restricted nutrition

    Dietary Supplement: Normal protein energy-restricted

  • Experimental
    Normal protein low carbohydrates

    Normal protein low carbohydrate energy-restricted diet

    Dietary Supplement: Normal protein energy-restricted

  • Experimental
    High protein normal carbohydrates

    High protein normal carbohydrates

    Dietary Supplement: High protein energy-restricted

  • Experimental
    High protein low carbohydrate

    High protein low carbohydrate nutrition

    Dietary Supplement: High protein energy-restricted

Interventions

  • Dietary supplementNormal protein energy-restricted

    Normal protein diet energy restricted

  • Dietary supplementHigh protein energy-restricted

    High protein diet, with either low or normal carbohydrate content

06

What researchers measure

Primary outcomes

  1. Body weight

    Time frame: 1 year

07

Study locations

1 site
  • Hospital Hengelo
    Hengelo, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00862953
Responsible party
Sponsor
First posted
Mar 17, 2009
Start date
Jul 2008
Primary completion
May 2010
Completion
Oct 2010
Last update
Apr 18, 2024

Study contacts

F NR Van Berkum, MD PhD
study director · Previtas Hengelo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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