NCT01642849

Brief Summary

This study will assess the effect of high protein (HP) and high carbohydrate (HC) diets on weight loss and other metabolic parameters. Rationale: The prevalence of obesity is on the rise in the US. The health hazards of obesity have been well established. The detrimental effects of obesity on cardiovascular, metabolic and psychological parameters as well as the excess cost to the national health budget are astounding. One way of treatment and prevention of obesity has been the use of diet and exercise. In the absence of well-established superiority of one diet over another, different scientifically unproven diets are in common use. A palatable diet providing satiety as well as all essential nutrients may go a long way in treating over-weight individuals. Another factor has been the long-term adherence to such weight loss regimens, which in general have been poor. Protein diets have been known to provide greater satiety and reduced energy intake than carbohydrate diets, but definite long-term studies are sparse. For this study the investigators will recruit and study 24 normal, pre-menopausal obese women (12 on HP diet and 12 on HC diet), and compare their weight loss and changes in metabolic parameters between the two diets.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

4 years

First QC Date

July 3, 2012

Last Update Submit

July 13, 2012

Conditions

ObesityInflammation

Keywords

high protein diethigh carbohydrate dietweight lossoxidative stressinflammationcardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • Effect of Diet Composition on Weight Change and Metabolic Parameters

    Outcome Measures: The effect of a high protein diet or a high carbohydrate diet provided to subjects for 6 months on metabolic parameters.

    6 months on High Protein or High Carbohydrate diet

Secondary Outcomes (1)

  • Effect of Diet Composition on Weight Change and Metabolic Parameters

    6 months on a high protein or high carbohydrate diet

Study Arms (2)

high protein diet

EXPERIMENTAL

12 subjects will be place on a high protein diet

Dietary Supplement: high protein dietDietary Supplement: high carbohydrate diet

high carbohydrate diet

EXPERIMENTAL

12 subjects will be put on a high carbohydrate diet for 6 months

Dietary Supplement: high carbohydrate diet

Interventions

high protein dietDIETARY_SUPPLEMENT

6 months on HP diet

high protein diet
high carbohydrate dietDIETARY_SUPPLEMENT

12 subjects will be placed on a hig carbohydrate diet for 6 months

high carbohydrate diethigh protein diet

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 20 yrs to 50 yrs,
  • BMI \> 30 kg/m2 to \< 55 kg/m2
  • Fasting glucose \< 110 mg/dl and 120 minute OGTT \< 170 mg/dl glucose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

RECRUITING

Related Publications (2)

  • Stentz FB, Lawson D, Tucker S, Christman J, Sands C. Decreased cardiovascular risk factors and inflammation with remission of type 2 diabetes in adults with obesity using a high protein diet: Randomized control trial. Obes Pillars. 2022 Dec 1;4:100047. doi: 10.1016/j.obpill.2022.100047. eCollection 2022 Dec.

    PMID: 37990670DERIVED

  • Stentz FB, Mikhael A, Kineish O, Christman J, Sands C. High protein diet leads to prediabetes remission and positive changes in incretins and cardiovascular risk factors. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1227-1237. doi: 10.1016/j.numecd.2020.11.027. Epub 2020 Dec 8.

    PMID: 33549435DERIVED

MeSH Terms

Conditions

ObesityInflammationWeight Loss

Interventions

Diet, High-ProteinDiet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBody Weight Changes

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, Carbohydrate-Restricted

Study Officials

  • Frankie B. Stentz, M.S., Ph.D.

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frankie B Stentz, M.S., Ph.D.

CONTACT

901-448-5803fstentz@uthsc.edu

Abbas E Kitabchi, M.D.

CONTACT

901-448-5803

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 17, 2012

Study Start

January 1, 2009

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

US(1)