Overweight and ObesityNCT04138303
Exercise and Nutrition on Obese Microbiome
A study testing Exercise Protocol, Calorie-Restrictive Low Carbohydrate Diet (CR-LC) and Ancestral Diet (AD) in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise Protocol, Calorie-Restrictive Low Carbohydrate Diet (CR-LC) and Ancestral Diet (AD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 21 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program
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.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise Protocol, Calorie-Restrictive Low Carbohydrate Diet (CR-LC), Ancestral Diet (AD)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Protocol |
| Exercise with CR-LC Group | Experimental | Participants will receive the exercise protocol and CR-LC Diet regimen. Receives: Other: Exercise Protocol; Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC) |
| Exercise with Ancestral Diet (AD) Group | Experimental | Participants will receive the exercise protocol and AD regimen. Receives: Other: Exercise Protocol; Other: Ancestral Diet (AD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal microbiota diversity
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Measured: Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Measured: 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
Measured: 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.
Measured: Baseline, 9 weeks
Change in leptin/adiponectin ratio
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Measured: Baseline, 9 weeks
Correlation of serum triglycerides with leptin levels
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Measured: Baseline, 9 weeks
Change in body weight
Change in body composition as evaluated as change in body weight measured in lbs.
Measured: 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.
Measured: Baseline, 9 weeks
Change in body composition
Change in body composition as evaluated as change in body fat and lean body mass percentage
Measured: Baseline, 9 weeks
Change in waist circumference
Change in waist circumference measured in inches.
Measured: Baseline, 9 weeks
Change in blood pressure
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Measured: 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).
Measured: Baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start21 Oct 2019
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesley Smith, University of Miami
- Investigators
- Wesley Smith, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138303
- Sponsor's protocol ID
- 20190936
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Calorie-Restrictive Low-Carbohydrate Diet Versus an Unrestrictive Ancestral Diet on Microbiota and Cardiometabolic Disease Markers of Obese Individuals Performing an Intense Exercise Program
- ClinicalTrials.gov ID
- NCT04138303
- Acronym / sponsor ID
- 20190936
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Only Group (EX) | Experimental | Other: Exercise ProtocolParticipants will only receive the exercise protocol without nutrition education or counseling and instructed to continue to consume their regular diet. |
| Exercise with CR-LC Group | Experimental | Other: Exercise Protocol, Other: Calorie-Restrictive Low Carbohydrate Diet (CR-LC)Participants will receive the exercise protocol and CR-LC Diet regimen. |
| Exercise with Ancestral Diet (AD) Group | Experimental | Other: Exercise Protocol, Other: Ancestral Diet (AD)Participants will receive the exercise protocol and AD regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProtocolThe 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. | Other | Exercise Only Group (EX), Exercise with Ancestral Diet (AD) Group, Exercise with CR-LC Group |
| Calorie-Restrictive Low Carbohydrate Diet (CR-LC)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). | Other | Exercise with CR-LC Group |
| Ancestral Diet (AD)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. | Other | Exercise with Ancestral Diet (AD) Group |
Primary outcome
Change in fecal microbiota diversity
Time frame: Baseline, 9 weeks
Change in fecal microbiota alpha-diversity will be assessed via stool sample evaluation
Change in Bacteriodetes/Firmicutes ratio
Time frame: Baseline, 9 weeks
Change in Bacteriodetes/Firmicutes ratio as assessed via stool sample evaluation
Percent change in fecal microbiota composition
Time frame: Baseline, 9 weeks
Percent change in Bacteriodetes phyla and percent change of short-chain fatty acid-producing species as assessed via stool sample evaluation
Change in inflammatory markers
Time frame: Baseline, 9 weeks
Change in serum inflammatory markers including Interleukin (IL)-1ß, IL-6, Tumor Necrosis Factor (TNF)-α and liposaccharide (LPS) evaluated in pg/ml.
Change in leptin/adiponectin ratio
Time frame: Baseline, 9 weeks
Change in serum adipose markers assessed as change in leptin/adiponectin ratio.
Correlation of serum triglycerides with leptin levels
Time frame: Baseline, 9 weeks
The correlation of the serum triglyceride levels will be evaluated against serum leptin levels.
Change in body weight
Time frame: Baseline, 9 weeks
Change in body composition as evaluated as change in body weight measured in lbs.
Change in resting metabolic rate
Time frame: Baseline, 9 weeks
Change in body composition as evaluated as change in resting metabolic rate measured in Calories per day.
Change in body composition
Time frame: Baseline, 9 weeks
Change in body composition as evaluated as change in body fat and lean body mass percentage
Change in waist circumference
Time frame: Baseline, 9 weeks
Change in waist circumference measured in inches.
Change in blood pressure
Time frame: Baseline, 9 weeks
Change in blood pressure assessed as systolic and diastolic pressure in mmHg.
Change in visceral fat
Time frame: Baseline, 9 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley Smith, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Protocol, Calorie-Restrictive Low Carbohydrate Diet (CR-LC) and Ancestral Diet (AD) in people with Overweight and Obesity, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal microbiota diversity (time frame: Baseline, 9 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.