An interventional study of Diet in Overweight and Obesity, sponsored by University of Houston. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by University of Houston · Not applicable, Interventional, and Prevention
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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Exclusion Criteria:
All participants will follow an ad libitum self-administered Paleo diet for 8-weeks
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Serum adipokines
Serum omentin (ng/mL) and nesfatin (ng/mL)
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Waist and hip circumference
Circumference of two midsection areas of the body (waist and hip) to estimate central adiposity
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Subcutaneous body fat
Skin fold thickness (mm) of body fat
Time frame: 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)
Time frame: 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)
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Blood pressure
Measurement of blood pressure from the arm (mmHg)
Time frame: Change from pre-intervention (week zero) and post-intervention (upon completion of week 8)
Body weight
Measurement of participant's body weight (kg)
Time frame: 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)
Time frame: pre-intervention (week zero)
Plan to share: Undecided — non-identifiable study variables (i.e. serum biomarkers) may be deposited in sharing databases for open access publications
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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