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| Name | Class |
|---|---|
| Chatham University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention | Experimental | All participants will follow an ad libitum self-administered Paleo diet for 8-weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Subcutaneous body fat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Carrillo | Chatham University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chatham University | Pittsburgh | Pennsylvania | 15232 | United States | ||
| University of Houston |
non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
Skin fold thickness (mm) of body fat
| Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) |
| 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) |
| 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) |
| Blood pressure | Measurement of blood pressure from the arm (mmHg) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) |
| Body weight | Measurement of participant's body weight (kg) | Change from pre-intervention (week zero) and post-intervention (upon completion of week 8) |
| Body height | Measurement of participant's height (m) to (along with body weight) calculate body mass index (kg/m^2) | pre-intervention (week zero) |
| Houston |
| Texas |
| 77204 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |