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

NCT03174769 | Completed

• 1 other identifier: 1701018623
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Body Composition

Outcome Measures

Primary Outcomes (3)

• Disordered sleep

  Will be assessed using the Actiwatch. Each participant will wear the Actiwatch on their wrist for 7 days as directed by the study coordinator. Outcome measurements include: real sleep time, latency, efficiency, wake time, and wake bouts.

  12 weeks

• Physiologic sleep onset

  All participants will be given saliva collection tubes and instruction on how to collect will be in the kit given. This for our lab to measure saliva melatonin concentrations during the 7 days they are wearing the Actiwatch. Subjects will collect saliva hourly from 5 hours before to 2 hours before usual sleep time, then every 30 minutes until 1 hour before usual sleep time. Subjects will be given collections tubes and detailed collection instructions prior to the testing period. After sample collection, you will place the saliva filled tubes in there protective container and place the container in your refrigerator. You will keep collected samples until testing for that period is complete and you return them to the study coordinator (≤ 7 days).

  12 weeks

• Subjective sleep quality

  Will be assessed using the Pittsburgh Sleep Quality Index questionnaire on a single testing day. The PSQI questionnaire is a clinical sleep behavior questionnaire validated for use in patients with insomnia, cancer, Parkinson's disease, and the general population. It is designed to assess indices of sleep during the preceding one-month interval and contains 19 questions using Likert scales from 0-3. All questions are categorized into seven sub-parameters (duration of sleep, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, subjective sleep quality, and use of sleeping medication). Each of these seven parameters is scored between 0 and 3 arbitrary units (au), which generates a summed total score of 0 to 21 au. This total score (GSS) of \>5 au indicates poor sleep condition. Thus, a lower GSS score indicates better sleep condition. The PSQI also has questions that generate routine sleep duration in hours.

  12 weeks

Secondary Outcomes (3)

• Fasting state blood analyses

  12 weeks

• Blood pressure

  12 weeks

• Body composition

  12 weeks

Study Arms (2)

Normal Protein with weight loss

ACTIVE COMPARATOR

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

Other: Normal protein

High protein and weight loss

EXPERIMENTAL

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

Other: High protien

Interventions

Normal protein OTHER

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

Normal Protein with weight loss

High protien OTHER

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

High protein and weight loss

Eligibility Criteria

• Age: 35 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetic, smoker

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

• 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.

  PMID: 33096550 DERIVED

Study Officials

• Wayne W Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: May 1, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)