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ObesityNCT00351845

Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight

A study testing Low carbohydrate diet (behavior) in people with Obesity, run by Provident Clinical Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the effects of a modified carbohydrate diet versus a portion controlled diet in overweight or obese men and women on body weight. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Low carbohydrate diet (behavior)
How many people
86 participants
Where
No sites listed yet
Study dates
Apr 2004to Dec 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women 18 to 65 years of age.
  • Waist circumference measurement at Visit 1 (week -1) of ³ 87 cm for females and ³ 90 cm for males.
  • Subject agrees to discontinue all use of supplements or multivitamins (except for those provided during study period) by Visit 2 (week 0).
  • Normally active and judged to be in good health on the basis of medical history and routine laboratory tests.
  • Subject must be willing to follow the assigned diet and maintain usual physical activity level throughout the trial.
  • Subject understands the procedures and requirements of the study by providing written informed consent and authorization for protected health information disclosure.

Who cannot join

  • Weight loss of > 10 lb in the two months prior to screening.
  • Body mass index (BMI) > 37.0 kg/m2.
  • Current smoker (any cigarette use) or history of smoking within 6 months prior to screening.
  • Postmenopausal women who are current users of hormone therapy or have discontinued hormone therapy within 2 months prior to screening.
  • History or presence of significant cardiac, renal, hepatic, pulmonary, biliary, or endocrine disorders.
  • Uncontrolled hypertension (systolic blood pressure ³ 160 mm Hg or diastolic blood pressure ³ 100 mm Hg on two consecutive visits).
Show all 26Show fewer
  • History of recurrent nephrolithiasis, or an acute episode of nephrolithiasis within the last year prior to screening.
  • History of symptomatic cholelithiasis, unless subject has undergone cholecystectomy.
  • History of gastrointestinal surgery for weight-reducing purposes.
  • Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes (controlled lactose intolerance or gastroesophageal reflux disease are acceptable.)
  • Pancreatic disease: pancreatic enzyme deficiency, history of pancreatitis.
  • Fasting blood glucose ≥ 126 mg/dL at visit 1 or diagnosed diabetes mellitus.
  • Use of any weight loss medications, supplements, programs, or meal replacement products intended to alter body weight within 4 weeks of the screening visit or during the course of the study. Occasional use of meal replacement bars or shakes as snacks is acceptable.
  • History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
  • Psychiatric disorders requiring medications (i.e., selective serotonin reuptake inhibitors) or which could interfere with the subject's compliance to the requirements of the protocol.
  • History or current presence of any diagnosed eating disorders (binge eating, bulimia, history of anorexia).
  • Use of systemic corticosteroids, androgens, or phenytoin.
  • Use of pseudo-ephedrine during the study period.
  • Use of lipid-lowering drugs or supplements, unless dose stable prior to enrollment (2 months prior for drugs, 2 weeks prior for supplements).
  • Use of drugs for regulating hemostasis, other than stable dose aspirin.
  • Use of thyroid hormones, except stable-dose replacement therapy for ≥ 2 months prior to enrollment.
  • Abnormal laboratory test results of clinical significance, including, but not limited to total cholesterol > 300 mg/dL or triglycerides > 400 mg/dL.
  • Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, post-tubal ligation, or ³ 1 year postmenopausal.
  • Recent history of (within past 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1 ½ oz distilled spirits).
  • Participation in another clinical study within 30 days prior to screening visit (week -1).
  • Individual has a condition the Investigator believes would interfere with the evaluation of the subject or put the subject at undue risk.

About this study

Official title: A Clinical Study to Evaluate the Effect of a Modified Carbohydrate Diet on Body Weight in Overweight or Obese Men and Women

The purpose of this study is to test the effects of a modified carbohydrate diet versus a portion controlled diet in overweight or obese men and women on body weight.

Conditions
Obesity
Being tested
Low carbohydrate diet (behavior)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low carbohydrate diet (behavior)Behavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences between and within modified carbohydrate and portion-controlled (control) diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body weight.

    Measured: week 12 and week 36

Secondary outcomes (2)

  1. Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body fat mass (FM).

    Measured: wwek 12 and week 36

  2. Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in trunk fat.

    Measured: week 12 and week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionNov 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351845
Sponsor's protocol ID
203470
Status last verified
Apr 2009
First submitted
11 Jul 2006
Last updated
22 Apr 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Low carbohydrate diet (behavior) in people with Obesity, run by Provident Clinical Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences between and within modified carbohydrate and portion-controlled (control) diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body weight. (time frame: week 12 and week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00351845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2009.

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