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Completed

NCT Number: NCT03814473

Paleo Diet 8wk Feasibility 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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chatham University, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • Chatham University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 24, 2019
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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