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

NCT ID: NCT03174769

Last Updated: 2019-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-10-30

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).

Conditions

Sleep; Body Composition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Normal Protein with weight loss

weight loss subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age

Meal Pattern USDA Healthy U.S.-Style Eating Pattern with ~5 oz eq of protein foods for 12 wk

Group Type: ACTIVE_COMPARATOR

Normal protein

Intervention Type: OTHER

Following a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk.

High protein and weight loss

weight loss subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age

Meal Pattern USDA Healthy U.S.-Style Eating Pattern with ~12.5 oz eq of protein foods for 12 wk

Group Type: EXPERIMENTAL

High protien

Intervention Type: OTHER

Following a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk.

Interventions

Normal protein

Following a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk.

Intervention Type: OTHER

High protien

Following a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne W Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33096550 (View on PubMed)

Other Identifiers

1701018623

Identifier Type: -

Identifier Source: org_study_id