Overweight and Obesity
Conditions
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.
Interventions
OTHERDiet
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
Sponsors
Chatham University
University of Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum cytokines | 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 | 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 | 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 | 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 | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | Serum omentin (ng/mL) and nesfatin (ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | Measurement of participant's body weight (kg) |
| Waist and hip circumference | 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 |
| Body height | pre-intervention (week zero) | Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m\^2) |
| Subcutaneous body fat | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | Skin fold thickness (mm) of body fat |
| Dietary composition | 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 | 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 | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) | Measurement of blood pressure from the arm (mmHg) |
Countries
United States
Outcome results
None listed