Paleo Diet 8wk Feasibility in Overweight Adults
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet
Sponsored by

About this trial
This is an interventional prevention trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
- smoking and/or smokeless tobacco users
- pregnancy
Sites / Locations
- Chatham University
- University of Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary intervention
Arm Description
All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
Outcomes
Primary Outcome Measures
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)
Serum growth factor
Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Serum biomarkers of energy homeostasis
Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
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)
Serum adipokines
Serum omentin (ng/mL) and nesfatin (ng/mL)
Secondary Outcome Measures
Waist and hip circumference
Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
Subcutaneous body fat
Skin fold thickness (mm) of body fat
Dietary composition
3-day food diary to approximate macronutrient composition (grams)
Dietary energy intake
3-day food diary to approximate total energy intake (kcal)
Blood pressure
Measurement of blood pressure from the arm (mmHg)
Body weight
Measurement of participant's body weight (kg)
Body height
Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)
Full Information
NCT ID
NCT03814473
First Posted
January 16, 2019
Last Updated
January 22, 2019
Sponsor
University of Houston
Collaborators
Chatham University
1. Study Identification
Unique Protocol Identification Number
NCT03814473
Brief Title
Paleo Diet 8wk Feasibility in Overweight Adults
Official Title
Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2015 (Actual)
Primary Completion Date
April 14, 2015 (Actual)
Study Completion Date
April 14, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
Chatham University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary intervention
Arm Type
Experimental
Arm Description
All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Serum cytokines
Description
Serum measurement of interleukin (IL)-4 (pg/dL), IL-10 (pg/dL), interferon (INF)-gamma (pg/dL), tumor necrosis factor (TNF; pg/dL)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Serum growth factor
Description
Serum measurement of brain derived neurotrophic factor (BDNF; ng/mL)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Serum biomarkers of energy homeostasis
Description
Serum fibroblast growth factor (FGF)-21 (pg/mL) and adiponectin (pg/mL)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Serum glucose metabolism biomarkers
Description
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)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Serum adipokines
Description
Serum omentin (ng/mL) and nesfatin (ng/mL)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary Outcome Measure Information:
Title
Waist and hip circumference
Description
Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Subcutaneous body fat
Description
Skin fold thickness (mm) of body fat
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Dietary composition
Description
3-day food diary to approximate macronutrient composition (grams)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Dietary energy intake
Description
3-day food diary to approximate total energy intake (kcal)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Blood pressure
Description
Measurement of blood pressure from the arm (mmHg)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Body weight
Description
Measurement of participant's body weight (kg)
Time Frame
Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Title
Body height
Description
Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)
Time Frame
pre-intervention (week zero)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
smoking and/or smokeless tobacco users
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Carrillo
Organizational Affiliation
Chatham University
Official's Role
Study Director
Facility Information:
Facility Name
Chatham University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications
Learn more about this trial
Paleo Diet 8wk Feasibility in Overweight Adults
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