NCT03814473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 16, 2019

Last Update Submit

January 22, 2019

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • Waist and hip circumference

    Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)

  • Subcutaneous body fat

    Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)

  • Dietary composition

    Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)

  • Dietary energy intake

    Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)

  • Blood pressure

    Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)

  • +2 more secondary outcomes

Study Arms (1)

Dietary intervention

EXPERIMENTAL

All participants will follow an ad libitum self-administered Paleo diet for 8-weeks

Other: Diet

Interventions

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

Dietary intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • known cardiovascular, metabolic (including type I or type II diabetes), or respiratory disease
  • smoking and/or smokeless tobacco users
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chatham University

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Andres Carrillo

    Chatham University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssitant Professor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 24, 2019

Study Start

January 19, 2015

Primary Completion

April 14, 2015

Study Completion

April 14, 2015

Last Updated

January 24, 2019

Record last verified: 2019-01

Locations

US(2)