NCT03093792

Brief Summary

The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

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

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

March 22, 2017

Last Update Submit

March 22, 2017

Conditions

Diet, Carbohydrate-Restricted

Outcome Measures

Primary Outcomes (11)

  • Effects of the Curves program on physical activity patterns

    24 weeks

  • Effects of the Curves program on body weight

    24 weeks

  • Effects of the Curves program on the hip/waist ratio

    24 weeks

  • Effects of the Curves program on Resting Energy Expenditure (REE)

    24 weeks

  • Effects of the Curves program on Blood Pressure (BP)

    24 weeks

  • Effects of the Curves program on Heart Rate (HR)

    24 weeks

  • Effects of the Curves program on body composition (DXA)

    24 weeks

  • Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)

    24 weeks

  • Effects of the Curves program on a chemistry-15 blood panel

    24 weeks

  • Effects of the Curves program on a cell blood count (CBC) blood panel

    24 weeks

  • Effects of the Curves program on lipid panels

    24 weeks

Secondary Outcomes (3)

  • Effects of the Curves program on maximal cardiopulmonary capacity

    24 weeks

  • Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test

    24 weeks

  • Effects of the Curves program on muscular endurance through a maximal repetition test

    24 weeks

Study Arms (4)

Control

PLACEBO COMPARATOR

(no diet or exercise intervention)

Other: Control

American Heart Association

EXPERIMENTAL

(AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise)

Other: American Heart Association plus exercise

Curves Complete - I

ACTIVE COMPARATOR

(CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise)

Other: Curves Complete - I plus exercise

Curves Complete - II

ACTIVE COMPARATOR

(CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)

Other: Curves Complete - II plus exercise

Interventions

ControlOTHER
Control
American Heart Association plus exerciseOTHER
American Heart Association
Curves Complete - I plus exerciseOTHER
Curves Complete - I
Curves Complete - II plus exerciseOTHER
Curves Complete - II

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe eligibility criteria were at the request of the study sponsor.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant is an apparently healthy female
  • The participant is between the ages of 18 and 60

You may not qualify if:

  • The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
  • The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
  • The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
  • The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
  • The participant is willing to participate in a regular moderate exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

American Heart AssociationExercise

Intervention Hierarchy (Ancestors)

Voluntary Health AgenciesOrganizations, NonprofitOrganizationsHealth Care Economics and OrganizationsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share