Paleo Diet 8wk Feasibility in Overweight Adults

Overview

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.

Full Title of Study: “Eight Week ad Libitum Self-prepared Paleo Diet and Cardiometabolic Disease Risk Factors in Overweight Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 14, 2015

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.

Interventions

  • Other: Diet
    • 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

Arms, Groups and Cohorts

  • Experimental: Dietary intervention
    • All participants will follow an ad libitum self-administered Paleo diet for 8-weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • Waist and hip circumference
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
  • Subcutaneous body fat
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • Skin fold thickness (mm) of body fat
  • Dietary composition
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • 3-day food diary to approximate macronutrient composition (grams)
  • Dietary energy intake
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • 3-day food diary to approximate total energy intake (kcal)
  • Blood pressure
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • Measurement of blood pressure from the arm (mmHg)
  • Body weight
    • Time Frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
    • Measurement of participant’s body weight (kg)
  • Body height
    • Time Frame: pre-intervention (week zero)
    • Measurement of participant’s height (m) to (along with body weight) calculate body mass index (kg/m^2)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Houston
  • Collaborator
    • Chatham University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Melissa M Markofski, Asssitant Professor – University of Houston
  • Overall Official(s)
    • Andres Carrillo, Study Director, Chatham University

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