Paleo Diet 8wk Feasibility in Overweight Adults

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814473
• Other study ID #: STUDY00000104
• Status: Completed
• Phase: N/A
• Start date: January 19, 2015
• Est. completion date: April 14, 2015

Study information

• Verified date: January 2019
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 14, 2015
• Est. primary completion date: April 14, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas
United States	Chatham University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	Chatham University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Subcutaneous body fat	Skin fold thickness (mm) of body fat	Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary	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)
Secondary	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)
Secondary	Blood pressure	Measurement of blood pressure from the arm (mmHg)	Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary	Body weight	Measurement of participant's body weight (kg)	Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Secondary	Body height	Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2)	pre-intervention (week zero)