HealthyNCT02380833
Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.
A study testing MyPlate, MyPlate + Exercise and Paleolithic in people with Healthy, run by Clemson University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MyPlate, MyPlate + Exercise and Paleolithic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2016
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body fat percent between 20 and 38
- less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task
- not pregnant, trying to become pregnant or lactating
- non-smoker
- no previous resistance training
- have not been on a diet in the past three months
- no dietary restrictions (food allergies, disease conditions, etc)
- have not lost more than 10 lbs. in the past three months
Who cannot join
- taking any medication
- women who have had a left breast mastectomy
- do not meet criteria of PAR-Q
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, on Physical Conditioning in Women: a Randomized Controlled Trial.
The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.
- Conditions
- Healthy
- Being tested
- MyPlate, MyPlate + Exercise, Paleolithic, Paleolithic + Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPlateBehavioural
To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
MyPlate + ExerciseBehavioural
To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
PaleolithicBehavioural
To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.
Paleolithic + ExerciseBehavioural
To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| MyPlate | Active comparator | To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks. Receives: Behavioral: MyPlate |
| MyPlate + Exercise | Active comparator | To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks. Receives: Behavioral: MyPlate + Exercise |
| Paleolithic | Active comparator | To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks. Receives: Behavioral: Paleolithic |
| Paleolithic + Exercise | Active comparator | To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks. Receives: Behavioral: Paleolithic + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aerobic conditioning
Peak oxygen consumption
Measured: Baseline and 8 weeks
Change in anaerobic power
Wingate anaerobic threshold
Measured: Baseline and 8 weeks
Change in strength
Chest press and leg press estimated one repetition maximum
Measured: Baseline and 8 weeks
Secondary outcomes (21)
Change in resting energy expenditure
24 hour kcal and respiratory quotient
Measured: Baseline and 8 weeks
Change in urine
Osmolality
Measured: Baseline and 8 weeks
Change in insulin (plasma)
Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in glucagon (plasma)
Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in ghrelin (plasma)
Total and active ghrelin; Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in peptide YY 3-36 (plasma)
Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in adiponectin (plasma)
Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in leptin (plasma)
Radioimmunoprecipitation assay
Measured: Baseline and 8 weeks
Change in tumor necrosis factor alpha (plasma)
ELISA
Measured: Baseline and 8 weeks
Change in interleukin 6 (plasma)
ELISA
Measured: Baseline and 8 weeks
Change in undercarboxylated osteocalcin (plasma)
enzymeimmunoassay
Measured: Baseline and 8 weeks
Change in total cholesterol (plasma)
Colorimetric enzyme assay
Measured: Baseline and 8 weeks
Change in HDL cholesterol (plasma)
Colorimetric enzyme assay
Measured: Baseline and 8 weeks
Change in non-HDL cholesterol (plasma)
Calculated from triacylglycerol, total cholesterol and HDL cholesterol
Measured: Baseline and 8 weeks
Change in triacylglycerol (plasma)
Colorimetric enzyme assay
Measured: Baseline and 8 weeks
Change in non-esterified fatty acids (plasma)
Colorimetric enzyme assay
Measured: Baseline and weeks
Change in glucose (plasma)
Colorimetric enzyme assay
Measured: Baseline and 8 weeks
Change in ketones (plasma)
Colorimetric enzyme assay
Measured: Baseline and 8 weeks
Change in fat mass
Dual energy x-ray absorptiometry
Measured: Baseline and 8 weeks
Change in fat free mass
Dual energy x-ray absorptiometry
Measured: Baseline and 8 weeks
Change in bone mass
Dual energy x-ray absorptiometry
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot D. Jesch, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380833
- Sponsor's protocol ID
- IRB2014-457
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2015
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, on Physical Conditioning in Women: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02380833
- Acronym / sponsor ID
- IRB2014-457
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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 determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MyPlate | Active comparator | Behavioral: MyPlateTo consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks. |
| MyPlate + Exercise | Active comparator | Behavioral: MyPlate + ExerciseTo consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks. |
| Paleolithic | Active comparator | Behavioral: PaleolithicTo consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks. |
| Paleolithic + Exercise | Active comparator | Behavioral: Paleolithic + ExerciseTo consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- body fat percent between 20 and 38
- less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task
- not pregnant, trying to become pregnant or lactating
- non-smoker
- no previous resistance training
Key exclusion criteria (3 listed)
- taking any medication
- women who have had a left breast mastectomy
- do not meet criteria of PAR-Q
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 |
|---|---|---|
| MyPlateTo consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks. | Behavioural | MyPlate |
| MyPlate + ExerciseTo consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks. | Behavioural | MyPlate + Exercise |
| PaleolithicTo consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks. | Behavioural | Paleolithic |
| Paleolithic + ExerciseTo consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks. | Behavioural | Paleolithic + Exercise |
Primary outcome
Change in aerobic conditioning
Time frame: Baseline and 8 weeks
Peak oxygen consumption
Change in anaerobic power
Time frame: Baseline and 8 weeks
Wingate anaerobic threshold
Change in strength
Time frame: Baseline and 8 weeks
Chest press and leg press estimated one repetition maximum
21 secondary outcomes
Change in resting energy expenditure
Time frame: Baseline and 8 weeks
Change in urine
Time frame: Baseline and 8 weeks
Change in insulin (plasma)
Time frame: Baseline and 8 weeks
Change in glucagon (plasma)
Time frame: Baseline and 8 weeks
Change in ghrelin (plasma)
Time frame: Baseline and 8 weeks
Change in peptide YY 3-36 (plasma)
Time frame: Baseline and 8 weeks
Change in adiponectin (plasma)
Time frame: Baseline and 8 weeks
Change in leptin (plasma)
Time frame: Baseline and 8 weeks
Change in tumor necrosis factor alpha (plasma)
Time frame: Baseline and 8 weeks
Change in interleukin 6 (plasma)
Time frame: Baseline and 8 weeks
Change in undercarboxylated osteocalcin (plasma)
Time frame: Baseline and 8 weeks
Change in total cholesterol (plasma)
Time frame: Baseline and 8 weeks
Change in HDL cholesterol (plasma)
Time frame: Baseline and 8 weeks
Change in non-HDL cholesterol (plasma)
Time frame: Baseline and 8 weeks
Change in triacylglycerol (plasma)
Time frame: Baseline and 8 weeks
Change in non-esterified fatty acids (plasma)
Time frame: Baseline and weeks
Change in glucose (plasma)
Time frame: Baseline and 8 weeks
Change in ketones (plasma)
Time frame: Baseline and 8 weeks
Change in fat mass
Time frame: Baseline and 8 weeks
Change in fat free mass
Time frame: Baseline and 8 weeks
Change in bone mass
Time frame: Baseline and 8 weeks
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 17 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPlate, MyPlate + Exercise and Paleolithic in people with Healthy, run by Clemson University 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 8 inclusion and 3 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 17 Nov 2016. 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 aerobic conditioning (time frame: Baseline and 8 weeks). The study lists 3 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 17 Nov 2016.