Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-29 @ 11:18 AM
Study NCT ID:
NCT03174769
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Protein Quantity Within the USDA Healthy Style Eating Pattern on Sleep
Sponsor:
Purdue University
Organization:
Study Overview
Official Title:
Effects of Higher Consumption of Protein-rich Animal Foods With the USDA Healthy U.S.-Style Eating Pattern on Sleep Quality and Cardio-metabolic Health in Overweight/Obese Adults During Diet-induced Weight Loss
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This evaluates the affect of protein quantity on indices of sleep. Half the participants will be prescribed protein in the amount consistent with the USDA healthy style eating pattern, while the other half will be prescribed a diet containing 12.5 oz eq of protein.
Detailed Description:
According to the National Sleep Foundation, 13% of U.S. adults were reported to sleep 6 hours or less per weeknight in 2001. Eight years later, the number increased to 20%. Also, the proportion of people experiencing a sleep problem (e.g. difficulties in initiating or maintaining sleep) several nights per week has increased dramatically (from 51% to 64% in 2001 to 2009). Getting enough and good quality sleep is essential to health. Indices of sleep, including duration, quality, and patterning are related to obesity, type 2 diabetes, cardiovascular disease, hypertension, worsen lipid-lipoprotein status, and premature death. All of these morbidities and mortality are also impacted by diet .
The 2015 Dietary Guidelines Advisory Committee recognized "an insufficient body of evidence" in the "emerging area" of "associations between sleep patterns, dietary intakes, and obesity risk" and that "a paucity of research exists on the potential impact of diet on sleep-related outcomes". Currently the majority of research has assessed the influence of sleep on energy balance or dietary choices. The reversed relation, how diet influence sleep, received much less attention. In general, diet-induced weight loss is considered to improve sleep quality and increase sleep duration. However, emerging research brings into question the impact of the macronutrient distribution during dietary energy restriction (ER) on indices of sleep. Dietary protein, due to its ability to provide tryptophan and tyrosine (precursors of neurotransmitters melatonin and dopamine), may influence sleep. Despite the fact that both diet and sleep predict obesity and chronic diseases, limited research exists on the effects of dietary energy and macronutrients, especially high-quality protein intake, on indices of sleep.
The primary aim is to assess the effects of the USDA Healthy U.S.-Style Eating Pattern with higher amounts of animal-based protein-rich foods (lean meats and eggs) on health outcomes including sleep and blood pressure.
This is a 16-week randomized, parallel, placebo-controlled, single-blind study. During baseline, participant's diet, general health, and sleep quality will be assessed. Participants will then be randomized and assigned to either the normal protein or high protein (5 vs. 12.5 oz-eq of protein foods daily) for the 12-week weight loss intervention with the energy-restriction (750 kcal/day dietary energy deficits).
The 2015 Dietary Guidelines Advisory Committee recognized "an insufficient body of evidence" in the "emerging area" of "associations between sleep patterns, dietary intakes, and obesity risk" and that "a paucity of research exists on the potential impact of diet on sleep-related outcomes". Currently the majority of research has assessed the influence of sleep on energy balance or dietary choices. The reversed relation, how diet influence sleep, received much less attention. In general, diet-induced weight loss is considered to improve sleep quality and increase sleep duration. However, emerging research brings into question the impact of the macronutrient distribution during dietary energy restriction (ER) on indices of sleep. Dietary protein, due to its ability to provide tryptophan and tyrosine (precursors of neurotransmitters melatonin and dopamine), may influence sleep. Despite the fact that both diet and sleep predict obesity and chronic diseases, limited research exists on the effects of dietary energy and macronutrients, especially high-quality protein intake, on indices of sleep.
The primary aim is to assess the effects of the USDA Healthy U.S.-Style Eating Pattern with higher amounts of animal-based protein-rich foods (lean meats and eggs) on health outcomes including sleep and blood pressure.
This is a 16-week randomized, parallel, placebo-controlled, single-blind study. During baseline, participant's diet, general health, and sleep quality will be assessed. Participants will then be randomized and assigned to either the normal protein or high protein (5 vs. 12.5 oz-eq of protein foods daily) for the 12-week weight loss intervention with the energy-restriction (750 kcal/day dietary energy deficits).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: