Atkins Diet and Prostate Cancer Clinical Trial

Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00932672

Enrollment

Registered

2009-07-03

Start date

2009-06-30

Completion date

2014-10-31

Last updated

2015-12-07

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Atkins

Brief summary

This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).

Detailed description

Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.

Interventions

BEHAVIORALAtkins Diet

Patients are given an outline of the Atkins diet and are asked to follow it for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate 2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months 3. Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion criteria

1. Symptomatic metastatic disease 2. Myocardial infarction within 6 months 3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.) 4. Patient consuming a low-carbohydrate diet 5. Medical conditions or co-morbidities that preclude participation in the protocol 6. Vegetarians

Design outcomes

Primary

Measure	Time frame
The primary end-point will be differences in insulin sensitivity between the arms	6 months

Secondary

Measure	Time frame
Measures will include other cardiac risk factors, overall body morphometrics, body composition as assessed by dual energy x-ray absorptiometry (DXA), and cancer control (PSA levels)	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026