ObesityUPLIFTNCT03074643
Utilizing Protein During Weight Loss to Impact Physical Function
A study testing Weight loss intervention months 0-6, Exercise intervention months 0-6 and Carbohydrate supplement for months 0-6 in people with Obesity and Weight Loss, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on physical function, muscle mass, and weight loss maintenance in obese older adults. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Obesity, Weight Loss, Diet Modification
- What is being tested?
- Weight loss intervention months 0-6, Exercise intervention months 0-6 and Carbohydrate supplement for months 0-6
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65-85 years
- BMI: 27-45 kg/m2
- No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
- eSPPB <2.5
- No contraindications for safe and optimal participation in exercise training
- Approved for participation by Medical Director (Dr. Lyles)
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- Willing to provide informed consent
- Agree to all study procedures and assessments
- Willing to consume protein/CHO supplements for up to 18 months
- Able to provide own transportation to study visits and intervention sessions
Who cannot join
- Weight loss (≥5%) in past 6 months
- Dependent on cane or walker
- Cognitive impairment (MoCA score <22)
- Severe arthritis, or other musculoskeletal disorder
- Joint replacement or other orthopedic surgery in past 6 months
- Uncontrolled resting hypertension (>160/90 mmHg);
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- Insulin-dependent or uncontrolled diabetes (HbA1c ≥8%)
- Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease requiring oxygen; uncontrolled endocrine/metabolic disease; neurological or hematological disease; cancer requiring treatment in past year, except non-melanoma skin cancers; liver or renal disease; or clinically evident edema
- Unstable, severe depression
- Serious conduction disorder, uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm at rest or ≥2 mm with exercise)
- Abnormal kidney function (eGFR <30 based on serum creatinine, age, gender, and race)
- Anemia (Hb<13 g/dL in men; <12 g/dL in women)
- Drug abuse or excessive alcohol use (>7 drinks/week women; >14 drinks/week men)
- Use of any tobacco or nicotine products in the past year
- Osteoporosis (T-score < -2.5 on hip or spine scan)
- Regular use of growth/steroid hormones, sex steroids or corticosteroids, osteoporosis medication, or protein supplements
- Weight loss medications or procedures
- Current participation in another intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
Geriatric Research Center at Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Long-term Effects of Weight Loss and Supplemental Protein on Physical Function
This study will evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Read the detailed description
The study will use a 3-group design in 225 obese (BMI 27-45 kg/m2), older (65-85 years) men and women at risk for disability (eSPPB <2.5) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves physical function compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of improved physical function. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Physical function (primary aim) will be assessed by the expanded Short Physical Performance Battery (primary outcome) and lower extremity muscle strength at baseline, 6-, 12- and 18-months. Weight loss maintenance and body composition (secondary aim) will be assessed by dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) at baseline, 6- and 18-months. Bone mineral density (DXA) and cardiometabolic risk factors will also be measured at baseline, 6- and 18-months.
- Conditions
- Obesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits
- Being tested
- Weight loss intervention months 0-6, Exercise intervention months 0-6, Carbohydrate supplement for months 0-6, Protein supplement for months 0-6, Protein supplement for follow-up months 7-18
- Medical subject headings
- Obesity, Weight Loss, Body Weight Changes, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss intervention months 0-6Behavioural
All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).
Exercise intervention months 0-6Behavioural
All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.
Carbohydrate supplement for months 0-6Dietary supplement
Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.
Protein supplement for months 0-6Dietary supplement
Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.
Protein supplement for follow-up months 7-18Dietary supplement
Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| RecProt | Placebo comparator | Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. Receives: Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: Carbohydrate supplement for months 0-6 |
| 6-mon HiProt | Active comparator | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Receives: Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: Protein supplement for months 0-6 |
| 18-mon HiProt | Active comparator | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases.
Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Receives: Behavioral: Weight loss intervention months 0-6; Behavioral: Exercise intervention months 0-6; Dietary Supplement: Protein supplement for months 0-6; Dietary Supplement: Protein supplement for follow-up months 7-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Short Physical Performance Battery Score
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function
Measured: 18 months
Secondary outcomes (6)
Lower Extremity Muscle Strength
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity muscle strength assessed using an isokinetic dynamometer (Biodex) over 18 months
Measured: 18 months
Weight Change
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in body weight over 18 months
Measured: 18 months
Total Body Lean Mass
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray (DXA) acquired total body lean mass over 18 months
Measured: 18 months
Total Body Fat Mass
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray acquired (DXA) total body fat mass over 18 months
Measured: 18 months
Thigh Muscle Volume
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh muscle volume over 18 months
Measured: 18 months
Intermuscular Adipose Tissue
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh intermuscular adipose tissue over 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start3 May 2017
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Denise Houston, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074643
- Sponsor's protocol ID
- IRB00038668
- Other IDs
- R01AG050656
- Acronym
- UPLIFT
- Status last verified
- Apr 2023
- First submitted
- 28 Feb 2017
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Weight Loss and Supplemental Protein on Physical Function
- ClinicalTrials.gov ID
- NCT03074643
- Acronym / sponsor ID
- UPLIFT / IRB00038668
- Conditions
- Obesity, Weight Loss, Diet Modification, Aging, Weight Change, Body, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 22 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
Detailed description
The study will use a 3-group design in 225 obese (BMI 27-45 kg/m2), older (65-85 years) men and women at risk for disability (eSPPB <2.5) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves physical function compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of improved physical function. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Physical function (primary aim) will be assessed by the expanded Short Physical Performance Battery (primary outcome) and lower extremity muscle strength at baseline, 6-, 12- and 18-months. Weight loss maintenance and body composition (secondary aim) will be assessed by dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) at baseline, 6- and 18-months. Bone mineral density (DXA) and cardiometabolic risk factors will also be measured at baseline, 6- and 18-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).
| Arm | Type | Receives |
|---|---|---|
| RecProt | Placebo comparator | Behavioral: Weight loss intervention months 0-6, Behavioral: Exercise intervention months 0-6, Dietary Supplement: Carbohydrate supplement for months 0-6Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. |
| 6-mon HiProt | Active comparator | Behavioral: Weight loss intervention months 0-6, Behavioral: Exercise intervention months 0-6, Dietary Supplement: Protein supplement for months 0-6Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. |
| 18-mon HiProt | Active comparator | Behavioral: Weight loss intervention months 0-6, Behavioral: Exercise intervention months 0-6, Dietary Supplement: Protein supplement for months 0-6, Dietary Supplement: Protein supplement for follow-up months 7-18Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 65-85 years
- BMI: 27-45 kg/m2
- No regular resistance training and/or aerobic exercise (>20 mins/d) for past 6 months
- eSPPB <2.5
- No contraindications for safe and optimal participation in exercise training
Key exclusion criteria (18 listed)
- Weight loss (≥5%) in past 6 months
- Dependent on cane or walker
- Cognitive impairment (MoCA score <22)
- Severe arthritis, or other musculoskeletal disorder
- Joint replacement or other orthopedic surgery in past 6 months
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 |
|---|---|---|
| Weight loss intervention months 0-6All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). | Behavioural | 18-mon HiProt, 6-mon HiProt, RecProt |
| Exercise intervention months 0-6All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults. | Behavioural | 18-mon HiProt, 6-mon HiProt, RecProt |
| Carbohydrate supplement for months 0-6Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. | Dietary supplement | RecProt |
| Protein supplement for months 0-6Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. | Dietary supplement | 18-mon HiProt, 6-mon HiProt |
| Protein supplement for follow-up months 7-18Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up. | Dietary supplement | 18-mon HiProt |
Primary outcome
Change in Expanded Short Physical Performance Battery Score
Time frame: 18 months
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function
6 secondary outcomes
Lower Extremity Muscle Strength
Time frame: 18 months
Weight Change
Time frame: 18 months
Total Body Lean Mass
Time frame: 18 months
Total Body Fat Mass
Time frame: 18 months
Thigh Muscle Volume
Time frame: 18 months
Intermuscular Adipose Tissue
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Denise Houston, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss intervention months 0-6, Exercise intervention months 0-6 and Carbohydrate supplement for months 0-6 in people with Obesity and Weight Loss, run by Wake Forest University Health Sciences 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 10 inclusion and 18 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 22 May 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Expanded Short Physical Performance Battery Score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.