NCT02190136

Brief Summary

Stretching and flexibility exercise such as yoga and functional resistance exercise are two forms of exercise that are growing in popularity. However, they have not been scientifically tested to demonstrate their ability to improve body composition, fitness, heart and metabolic health, and mood state in overweight/obese women. The investigators hypothesize that during an 11 week intervention, both forms of exercise will improve body composition, heart and metabolic health and mood state.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

December 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

July 7, 2014

Last Update Submit

July 11, 2014

Conditions

ObesityInsulin Resistance

Keywords

obesityprotein-rich whole foods dietaerobic fitnessresistance trainingstretching/yoga trainingglycemiamood state

Outcome Measures

Primary Outcomes (1)

  • Total and Regional Body Composition

    Total and regional body composition was assessed by dual energy xray absorptiometry (DXA) at baseline and 11 weeks in all subjects

    baseline and 11 weeks

Secondary Outcomes (1)

  • Aerobic Fitness

    baseline and 11 weeks

Other Outcomes (1)

  • Plasma Biomarkers

    baseline and 11 weeks

Study Arms (3)

Protein whole foods

ACTIVE COMPARATOR

Ingestion of 20-25 grams per serving consumed 4-6 times per day; 1 within an hour of waking in the morning and the other 2.5-3 hours apart during the day.

Other: Protein whole foodsOther: Protein Resistance Exercise TrainingOther: Protein Stretching/Yoga Training

Protein Resistance Exercise Training

EXPERIMENTAL

Ingestion of 4-6 protein-rich meals per day and 3 times per week of resistance functional training.

Other: Protein whole foodsOther: Protein Resistance Exercise Training

Protein Stretching/Yoga Training

EXPERIMENTAL

Ingestion of Protein-rich diet 4-6 meals/day and stretching/yoga training 3 times per week

Other: Protein whole foodsOther: Protein Stretching/Yoga Training

Interventions

Protein whole foodsOTHER

Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day

Protein Resistance Exercise TrainingProtein Stretching/Yoga TrainingProtein whole foods
Protein Resistance Exercise TrainingOTHER

Protein rich whole foods diet and resistance training 3 times per week for 11 weeks

Protein Resistance Exercise TrainingProtein whole foods
Protein Stretching/Yoga TrainingOTHER

Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks

Protein Stretching/Yoga TrainingProtein whole foods

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • obese or overweight women
  • between ages 25-60 and
  • otherwise healthy

You may not qualify if:

  • smokers,
  • habitual exercisers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition and Metabolism Laboratory

Saratoga Springs, New York, 12866, United States

Location

Related Publications (1)

  • Ruby M, Repka CP, Arciero PJ. Comparison of Protein-Pacing Alone or With Yoga/Stretching and Resistance Training on Glycemia, Total and Regional Body Composition, and Aerobic Fitness in Overweight Women. J Phys Act Health. 2016 Jul;13(7):754-64. doi: 10.1123/jpah.2015-0493. Epub 2016 Feb 19.

    PMID: 26901102DERIVED

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Paul J Arciero, PhD

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Health and Exercise Sciences Department

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 15, 2014

Study Start

December 1, 2006

Primary Completion

January 1, 2008

Study Completion

July 1, 2014

Last Updated

July 15, 2014

Record last verified: 2014-07

Locations

US(1)