Impact of Protein Quantity Within the USDA Healthy Style Eating Pattern on Sleep



Status:Recruiting
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:35 - 65
Updated:3/23/2019
Start Date:May 1, 2017
End Date:September 30, 2019
Contact:Wayne W Campbell, PhD
Email:campbeww@purdue.edu
Phone:(765) 494-8236

Use our guide to learn which trials are right for you!

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

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.

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).

Inclusion Criteria:

- Male or female; age 35-65 y; BMI 25-38 kg∙m-2; weight stable (± 3 kg) 3 months
pre-study; no acute illness; not diabetic; not pregnant or lactating; not currently
(or within 3 months pre-study) following an exercise or weight loss program;
non-smoking; not lactose intolerant; natural waist circumference ≥ 102 cm for men and
≥ 88 cm for women; fasting glucose < 110 mg/dL, systolic and diastolic blood pressures
< 140/90 mmHg; serum total cholesterol < 260 mg/dL; LDL-cholesterol < 160 mg/dL;
triacylglycerol < 400 mg/dL; PSQI score ≥ 5; and clinically normal serum albumin and
pre-albumin concentrations. In addition, subjects who have been diagnosed by their
doctor with moderate to severe sleep apnea or insomnia will be excluded during
screening.

Exclusion Criteria:

- Diabetic, smoker
We found this trial at
1
site
West Lafayette, Indiana 47907
Phone: 765-496-6342
?
mi
from
West Lafayette, IN
Click here to add this to my saved trials