SleepNCT03174769
Impact of Protein Quantity Within the USDA Healthy Style Eating Pattern on Sleep
A study testing Normal protein and High protien in people with Sleep and Body Composition, run by Purdue University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Body Composition
- What is being tested?
- Normal protein and High protien
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetic, smoker
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Normal protein, High protien
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal proteinOther
Following a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk.
High protienOther
Following a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: High protien |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
Fasting state blood analyses
clinical blood chemistries
Measured: 12 weeks
Blood pressure
24 h and clinical blood pressures
Measured: 12 weeks
Body composition
BodPod
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 May 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Wayne W Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174769
- Sponsor's protocol ID
- 1701018623
- Status last verified
- Dec 2019
- First submitted
- 31 May 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33096550
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03174769
- Acronym / sponsor ID
- 1701018623
- Conditions
- Sleep, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Protein with weight loss | Active comparator | Other: Normal proteinweight 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 |
| High protein and weight loss | Experimental | Other: High protienweight 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 |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Diabetic, smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal proteinFollowing a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk. | Other | Normal Protein with weight loss |
| High protienFollowing a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk. | Other | High protein and weight loss |
Primary outcome
Disordered sleep
Time frame: 12 weeks
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.
Physiologic sleep onset
Time frame: 12 weeks
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).
Subjective sleep quality
Time frame: 12 weeks
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.
3 secondary outcomes
Fasting state blood analyses
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Derived from this study: PubMed 33096550Hudson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne W Campbell, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal protein and High protien in people with Sleep and Body Composition, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disordered sleep (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174769, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.