NCT04138303

Brief Summary

The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

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

October 21, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

October 22, 2019

Last Update Submit

January 3, 2020

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (12)

  • Change in fecal microbiota diversity

    Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation

    Baseline, 9 weeks

  • Change in Bacteriodetes/Firmicutes ratio

    Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation

    Baseline, 9 weeks

  • Percent change in fecal microbiota composition

    Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation

    Baseline, 9 weeks

  • Change in inflammatory markers

    Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.

    Baseline, 9 weeks

  • Change in leptin/adiponectin ratio

    Change in serum adipose markers assessed as change in leptin/adiponectin ratio.

    Baseline, 9 weeks

  • Correlation of serum triglycerides with leptin levels

    The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.

    Baseline, 9 weeks

  • Change in body weight

    Change in body composition as evaluated as change in body weight measured in lbs.

    Baseline, 9 weeks

  • Change in resting metabolic rate

    Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.

    Baseline, 9 weeks

  • Change in body composition

    Change in body composition as evaluated as change in body fat and lean body mass percentage

    Baseline, 9 weeks

  • Change in waist circumference

    Change in waist circumference measured in inches.

    Baseline, 9 weeks

  • Change in blood pressure

    Change in blood pressure assessed as systolic and diastolic pressure in mmHg.

    Baseline, 9 weeks

  • Change in visceral fat

    Change in visceral fat levels will be measured using InBody570 with scores ranging from 1-20, with the higher score indicating increased visceral fat (worse outcome).

    Baseline, 9 weeks

Study Arms (3)

Exercise Only Group (EX)

EXPERIMENTAL

Participants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet.

Other: Exercise Protocol

Exercise with CR-LC Group

EXPERIMENTAL

Participants will receive the exercise protocol and CR-LC Diet regimen.

Other: Exercise ProtocolOther: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)

Exercise with Ancestral Diet (AD) Group

EXPERIMENTAL

Participants will receive the exercise protocol and AD regimen.

Other: Exercise ProtocolOther: Ancestral Diet (AD)

Interventions

Exercise ProtocolOTHER

The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise. Exercises are performed in person as a group with other participating subjects and lead by certified instructors. Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.

Exercise Only Group (EX)Exercise with Ancestral Diet (AD) GroupExercise with CR-LC Group
Calorie-Restrictive Low Carbohydrate Diet (CR-LC)OTHER

Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. CR-LC consists of caloric and macronutrient restrictions. Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure. Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).

Exercise with CR-LC Group
Ancestral Diet (AD)OTHER

Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. AD consists of consuming only whole foods and avoiding processed foods. Emphasis will be on food quality with no caloric or macronutrient restrictions.

Exercise with Ancestral Diet (AD) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
  • Individuals who volunteer for the 54-day exercise program.
  • Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
  • Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
  • Individuals who are not taking probiotics.
  • Individuals who are not taking Metformin.
  • Individuals who are cleared by their physician to perform strenuous exercise.
  • Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
  • Individuals who are between 18 and 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wesley Smith, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

October 21, 2019

Primary Completion

December 21, 2019

Study Completion

December 21, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)