Overweight and ObesityNCT03814473
Paleo Diet 8wk Feasibility in Overweight Adults
A study testing Diet in people with Overweight and Obesity, run by University of Houston at 2 sites in United States.
Trial summary
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jan 2015to 14 Apr 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-55 years
- BMI > 25 kg/m2
- Currently consuming a typical Western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain)
Who cannot join
- known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
- smoking and/or smokeless tobacco users
- pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Houston
Houston, Texas, 77204
Chatham University
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period.
Read the detailed description
The Paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. The feasibility of the Paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet follow an ad libitum self-administered Paleo diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers. Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm Western diet consumption at pre-, track compliance, and to assess dietary changes.
- Conditions
- Overweight and Obesity
- Being tested
- Diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Participants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular "paleolithic" diet
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | All participants will follow an ad libitum self-administered Paleo diet for 8-weeks Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cytokines
Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum growth factor
Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum biomarkers of energy homeostasis
Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum glucose metabolism biomarkers
leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum adipokines
Serum omentin (ng/mL) and nesfatin (ng/mL)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary outcomes (7)
Waist and hip circumference
Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Subcutaneous body fat
Skin fold thickness (mm) of body fat
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Dietary composition
3-day food diary to approximate macronutrient composition (grams)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Dietary energy intake
3-day food diary to approximate total energy intake (kcal)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Blood pressure
Measurement of blood pressure from the arm (mmHg)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Body weight
Measurement of participant's body weight (kg)
Measured: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Body height
Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)
Measured: pre-intervention (week zero)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start19 Jan 2015
- Primary completion14 Apr 2015
- Study completion14 Apr 2015
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Chatham University
- Responsible party
- Principal investigator, Melissa M Markofski, University of Houston
- Investigators
- Andres Carrillo, Study director, Chatham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814473
- Sponsor's protocol ID
- STUDY00000104
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults
- ClinicalTrials.gov ID
- NCT03814473
- Acronym / sponsor ID
- STUDY00000104
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Chatham University
- Study start
- 19 Jan 2015 (actual)
- Primary completion
- 14 Apr 2015 (actual)
- Study completion
- 14 Apr 2015 (actual)
- First posted
- 24 Jan 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.
Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and body composition will be measured before and after the intervention period.
Detailed description
The Paleo diet is a dietary method that is gaining popularity among the general population due to potential weight loss and disease prevention benefits. The feasibility of the Paleo diet and the effectiveness of self-administration in improving cardiometabolic disease risk factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight, physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults habitually eating a traditional Western diet follow an ad libitum self-administered Paleo diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers. Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the intervention to confirm Western diet consumption at pre-, track compliance, and to assess dietary changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: DietAll participants will follow an ad libitum self-administered Paleo diet for 8-weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-55 years
- BMI > 25 kg/m2
- Currently consuming a typical Western diet (high carbohydrate, low fat diet), which will be assessed using the 3-day dietary record (public domain)
Key exclusion criteria (3 listed)
- known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
- smoking and/or smokeless tobacco users
- pregnancy
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 |
|---|---|---|
| DietParticipants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular "paleolithic" diet | Other | Dietary intervention |
Primary outcome
Serum cytokines
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
Serum growth factor
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Serum biomarkers of energy homeostasis
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
Serum glucose metabolism biomarkers
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
leptin (mg/dL), glucagon-like peptide (GLP)-1 (mg/dL), resistin (mg/dL), insulin (mg/dL), Gastric inhibitory polypeptide (GIP; mg/dL), glucagon (mg/dL), visfatin (mg/dL), ghrelin (mg/dL), plasminogen activator inhibitor (PAI)-1 (mg/dL), C-peptide (mg/dL)
Serum adipokines
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum omentin (ng/mL) and nesfatin (ng/mL)
7 secondary outcomes
Waist and hip circumference
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Subcutaneous body fat
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Dietary composition
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Dietary energy intake
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Blood pressure
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Body weight
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Body height
Time frame: pre-intervention (week zero)
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 24 Jan 2019.
- Individual participant dataSharing planned: Undecided. non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications
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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.
Andres Carrillo study director
Chatham University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Overweight and Obesity, run by University of Houston at 2 sites 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 3 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 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Serum cytokines (time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)). The study lists 5 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 24 Jan 2019.