Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01006343
Other study ID # 0504001915
Secondary ID
Status Completed
Phase N/A
First received October 30, 2009
Last updated September 23, 2013

Study information

Verified date October 2009
Source Purdue University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The entire study protocol will last 13 weeks. Women will be randomly assigned to one of two experimental groups: high and low protein. All women will consume their unrestricted habitual diet during week 1 while baseline testing and measurements are taken. Starting at week 2, women in both groups will be counseled to consume a 750 kcal/day energy deficit diet containing either the RDA (LP group) or more than the recommended dietary allowance (RDA) (HP group) for protein. The energy restriction period will continue for 12 weeks (through study week 13) and is expected to result in body weight reduction of approximately 17 pounds. Testing and measurements will be repeated during week 13.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Eligible women will have a body mass index (BMI: weight (kg)/height (m2)) ranging from 26-36.

- Must be at least 21 years old.

Exclusion Criteria:

- Women with medical conditions that might place them at risk for participating in the study or interfere with the successful completion of the study protocol will be excluded.

- BMI <26 or >36.

- Younger than 21 years old.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Higher Protein (HP)

Lower Protein (LP)


Locations

Country Name City State
United States Purdue University West Lafayette Indiana

Sponsors (1)

Lead Sponsor Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Terminated NCT03316105 - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Active, not recruiting NCT04353726 - Knowledge-based Dietary Weight Management. N/A
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02877004 - LLLT for Reducing Waste Circumference and Weight N/A
Active, not recruiting NCT04327141 - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Recruiting NCT05249465 - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention N/A
Recruiting NCT05942326 - Sleep Goal-focused Online Access to Lifestyle Support N/A
Completed NCT00535600 - Effects of Bariatric Surgery on Insulin
Not yet recruiting NCT03601273 - Bariatric Embolization Trial for the Obese Nonsurgical Phase 1
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT02945410 - Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT02948517 - Time Restricted Feeding for Weight Loss and Cardio-protection N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Recruiting NCT02559479 - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes N/A