Paleo Diet 8wk Feasibility in Overweight Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary intervention<br>All participants will follow an ad libitum self-administered Paleo diet for 8-weeks | Other: Diet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | 
| Serum adipokines | Serum omentin (ng/mL) and nesfatin (ng/mL) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist and hip circumference | Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | 
| Subcutaneous body fat | Skin fold thickness (mm) of body fat | 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) | 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) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | 
| Blood pressure | Measurement of blood pressure from the arm (mmHg) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | 
| Body weight | Measurement of participant's body weight (kg) | 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) | pre-intervention (week zero) |