Clinical trial NCT03174769: Impact of Protein Quantity Within the USDA Healthy Style Eating Pattern on Sleep
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Body Composition
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 71
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: Inclusion Criteria:

* Male or female; age 35-65 y; BMI 25-39 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

Primary outcomes:
measure: Disordered sleep
timeFrame: 12 weeks
measure: Physiologic sleep onset
timeFrame: 12 weeks
measure: Subjective sleep quality
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting state blood analyses
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudson JL, Zhou J, Campbell WW. Adults Who Are Overweight or Obese and Consuming an Energy-Restricted Healthy US-Style Eating Pattern at Either the Recommended or a Higher Protein Quantity Perceive a Shift from "Poor" to "Good" Sleep: A Randomized Controlled Trial. J Nutr. 2020 Dec 10;150(12):3216-3223. doi: 10.1093/jn/nxaa302.