Clinical trial NCT03814473: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Chatham University
First posted: 2019-01-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Serum cytokines
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Serum growth factor
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Serum biomarkers of energy homeostasis
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Serum glucose metabolism biomarkers
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Serum adipokines
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary outcomes:
measure: Waist and hip circumference
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Subcutaneous body fat
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Dietary composition
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Dietary energy intake
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Blood pressure
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Body weight
timeFrame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
measure: Body height
timeFrame: pre-intervention (week zero)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Chatham University
state: Pennsylvania
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: Chatham University
name: Andres Carrillo
role: STUDY_DIRECTOR
References: