Obesity & OverweightNCT07806838
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
A study testing Whey Protein Supplementation and Mixed Spice Capsules in people with Obesity & Overweight and Muscle Mass and Strength, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This pilot study will examine whether daily protein supplementation with or without a mixture of culinary spices can help preserve muscle mass and function in adults who are using GLP-1 medications for weight management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Muscle Mass and Strength, Muscle Function
- What is being tested?
- Whey Protein Supplementation and Mixed Spice Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age at screening visit.
- BMI >27 kg/m² with weight-related conditions OR BMI >30 kg/m².
- Taking any FDA-approved GLP-1 medication, daily oral or weekly injectable, started up to three months ago, and experiencing at least 1 lb of weight loss per week.
- Screening laboratory tests without significant abnormalities that might interfere with the study.
Who cannot join
- Consume spices regularly >5 g/day.
- Allergy or sensitivity to spices, or history of allergy or anaphylaxis of any kind.
- Diagnosed with Type 2 diabetes.
- Vegans/vegetarians.
- Consuming protein, amino acid, or creatine supplements; occasional or infrequent use (1 serving per week or less) is allowed.
- Milk protein allergy.
Show all 20Show fewer
- Severe lactose intolerance.
- Current diagnosis of alcoholism or substance addiction.
- Uncontrolled hypertension (systolic BP >170 or diastolic BP >100).
- Eating a high-fiber/polyphenol diet or taking medication or dietary supplements that interfere with the absorption of polyphenols.
- Frequently using prebiotics, probiotics, yogurt, and/or fiber supplements.
- Pregnant, breastfeeding, or unwilling to practice birth control during study participation.
- Presence of a condition or abnormality that, in the opinion of the investigator, would compromise participant safety or data quality.
- Renal impairment measured as eGFR <45 mL/min/1.73 m² (<60 mL/min/1.73 m² in subjects treated with SGLT2i), according to the CKD-EPI creatinine equation as defined by KDIGO 2012.
- Any unstable medical conditions or terminal diagnosis.
- Unstable thyroid disease-not taking medication or medication dosage changed one or more times over the last 6 months. Stable thyroid disease on an unchanged prescription medication dose for ≥6 months is acceptable.
- Current use of insulin or oral medication of metformin, SU, SGLT2i, glitazone, or DPP4 as single-agent therapy or combination oral agents.
- Taking GLP-1 medications for more than 3 months.
- Have a medical implant or other metal implant, including a pacemaker.
- Unwilling to stay on a GLP-1 medication for 6 months or for the duration of study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA Center for Human Nutrition
Los Angeles, California, 90024
Hila Zelicha, 310-206-8292, uclanutrition@gmail.com
About this study
Official title: The Effect of Daily Mixed Spice Consumption and Protein Supplementation on Muscle Mass and Function in Adults Using GLP-1 Agonists for Weight Management: A Pilot Study
This pilot study will examine whether daily protein supplementation with or without a mixture of culinary spices can help preserve muscle mass and function in adults who are using GLP-1 medications for weight management.
The study will include 75 adults who recently started a GLP-1 medication and are experiencing weight loss. Participants will be randomly assigned to one of three groups: standard of care, protein supplementation plus placebo capsules, or protein supplementation plus mixed spice capsules. The study will last 6 months.
Researchers will compare changes in muscle mass and muscle function among the groups. Muscle mass will be measured using DEXA and D3-creatine enrichment. Muscle function will be assessed using walking, stair-climbing, and grip-strength tests. The study will also evaluate metabolic and inflammatory markers, body composition, dietary intake, physical activity, fatigue, sleep quality, quality of life, and other measures related to muscle health.
- Being tested
- Whey Protein Supplementation, Maltodextrin Placebo Capsules, Mixed Spice Capsules
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein SupplementationDietary supplement
Participants will receive Nutrasumma 100% Whey Protein Isolate (unflavored), providing 20 g whey protein isolate per serving. The 20 g of protein from the shake will count toward the total daily protein goal of 1.2 g/kg lean body mass/day. The remaining protein target will be met through the participant's usual diet.
Maltodextrin Placebo CapsulesDietary supplement
Participants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months.
Mixed Spice CapsulesDietary supplement
Participants will consume 4 g of mixed spice capsules daily for 6 months. The daily mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Standard of Care | No intervention | Participants will continue their prescribed GLP-1 medication and routine clinical management under the direction of their treating healthcare provider. The study will not determine GLP-1 medication selection, dosing, dose adjustments, or clinical management. Participants will receive standardized dietary/calorie and physical activity guidance and will complete the same study assessments and follow-up visits as participants in the intervention groups. They will not receive the study protein supplement, spice capsules, or placebo capsules. |
| Protein Supplementation + Placebo | Placebo comparator | Participants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg lean body mass per day, based on baseline lean body mass measured by DEXA, plus placebo capsules containing 4 g of maltodextrin daily for 6 months. Participants will also receive standardized dietary/calorie and physical activity guidance. Receives: Dietary Supplement: Whey Protein Supplementation; Dietary Supplement: Maltodextrin Placebo Capsules |
| Protein Supplementation + Mixed Spices | Experimental | Participants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg lean body mass per day, based on baseline lean body mass measured by DEXA, plus 4 g of mixed spice capsules daily for 6 months. The daily spice mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme. Participants will also receive standardized dietary/calorie and physical activity guidance. Receives: Dietary Supplement: Whey Protein Supplementation; Dietary Supplement: Mixed Spice Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Mass Measured by DEXA
Muscle mass will be assessed using dual-energy X-ray absorptiometry (DEXA). Change in muscle mass from baseline to 6 months will be compared among the three study groups.
Measured: Baseline, 3 months, and 6 months
Change in Muscle Mass Measured by D3-Creatine Enrichment
Muscle mass will be assessed using the D3-creatine (D3Cr) dilution method. Change in muscle mass from baseline to 6 months will be compared among the three study groups. Urinary D3-creatine enrichment will be measured by liquid chromatography with tandem mass spectrometry and used to estimate total body skeletal muscle mass.
Measured: Baseline and 6 months
Secondary outcomes (18)
Change in 400-Meter Walk Test Performance
Muscle function will be assessed using the 400-meter walk test.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Stair Climbing Test Performance
Muscle function will be assessed using a stair climbing test.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Grip Strength
Grip strength will be measured using a handheld dynamometer and recorded in kilograms. The best of three trials for each hand will be used in the analysis.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Mitochondrial Function
Mitochondrial function will be assessed in peripheral blood mononuclear cells (PBMCs), including autophagy and mitochondrial assays.
Measured: Baseline, 3 months, and 6 months
Change in Fasting Glucose
Fasting glucose will be measured to assess glucose homeostasis.
Measured: Baseline, 3 months, and 6 months
Change in Fasting Insulin
Fasting insulin will be measured to assess insulin sensitivity.
Measured: Time Frame: Baseline to 6 months
Change in C-Peptide
Description: Fasting C-peptide will be measured as a marker of pancreatic beta-cell function.
Measured: Baseline, 3 months, and 6 months
Change in Glucagon
Description: Fasting glucagon will be measured as a metabolic marker.
Measured: Baseline, 3 months, and 6 months
Change in Glucose-Dependent Insulinotropic Polypeptide (GIP)
Fasting GIP will be measured to evaluate metabolic pathways related to glucose regulation.
Measured: Baseline, 3 months, and 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Description: High-sensitivity C-reactive protein will be measured as a marker of systemic inflammation.
Measured: Time Frame: Baseline, 3 months, and 6 months
Change in Body Weight
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Body Composition by Bioelectrical Impedance Analysis
Body composition will be assessed using an InBody bioelectrical
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Fatigue Assessed by PROMIS Fatigue Short Form 8a
Fatigue will be assessed using the PROMIS Fatigue Short Form 8-item questionnaire.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Quality of Life Assessed by SF-36
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Dietary Energy and Macronutrient Intake
Dietary energy and macronutrient intake will be assessed using 24-hour dietary recalls.
Measured: Baseline, 1 month, 3 months, 4.5 months, and 6 months
Change in Physical Activity
Physical activity will be monitored using step counts from participants' personal devices and self-reported physical activity recorded using MyNetDiary.
Measured: Baseline, 1 month, 3 months, 4.5 months, and 6 months
Change in Gut Microbiome Composition
Gut microbiome composition will be assessed using fecal samples
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806838
- Sponsor's protocol ID
- 25-0763
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Mixed Spice Consumption and Protein Supplementation on Muscle Mass and Function in Adults Using GLP-1 Agonists for Weight Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT07806838
- Acronym / sponsor ID
- 25-0763
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Sep 2026 (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 pilot study will examine whether daily protein supplementation with or without a mixture of culinary spices can help preserve muscle mass and function in adults who are using GLP-1 medications for weight management.
The study will include 75 adults who recently started a GLP-1 medication and are experiencing weight loss. Participants will be randomly assigned to one of three groups: standard of care, protein supplementation plus placebo capsules, or protein supplementation plus mixed spice capsules. The study will last 6 months.
Researchers will compare changes in muscle mass and muscle function among the groups. Muscle mass will be measured using DEXA and D3-creatine enrichment. Muscle function will be assessed using walking, stair-climbing, and grip-strength tests. The study will also evaluate metabolic and inflammatory markers, body composition, dietary intake, physical activity, fatigue, sleep quality, quality of life, and other measures related to muscle health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Standard of Care | No intervention | –Participants will continue their prescribed GLP-1 medication and routine clinical management under the direction of their treating healthcare provider. The study will not determine GLP-1 medication selection, dosing, dose adjustments, or clinical management. Participants will receive standardized dietary/calorie and physical activity guidance and will complete the same study assessments and follow-up visits as participants in the intervention groups. They will not receive the study protein supplement, spice capsules, or placebo capsules. |
| Protein Supplementation + Placebo | Placebo comparator | Dietary Supplement: Whey Protein Supplementation, Dietary Supplement: Maltodextrin Placebo CapsulesParticipants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg lean body mass per day, based on baseline lean body mass measured by DEXA, plus placebo capsules containing 4 g of maltodextrin daily for 6 months. Participants will also receive standardized dietary/calorie and physical activity guidance. |
| Protein Supplementation + Mixed Spices | Experimental | Dietary Supplement: Whey Protein Supplementation, Dietary Supplement: Mixed Spice CapsulesParticipants will receive protein supplementation with a goal of total protein intake of 1.2 g/kg lean body mass per day, based on baseline lean body mass measured by DEXA, plus 4 g of mixed spice capsules daily for 6 months. The daily spice mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme. Participants will also receive standardized dietary/calorie and physical activity guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥18 years of age at screening visit.
- BMI >27 kg/m² with weight-related conditions OR BMI >30 kg/m².
- Taking any FDA-approved GLP-1 medication, daily oral or weekly injectable, started up to three months ago, and experiencing at least 1 lb of weight loss per week.
- Screening laboratory tests without significant abnormalities that might interfere with the study.
Key exclusion criteria (20 listed)
- Consume spices regularly >5 g/day.
- Allergy or sensitivity to spices, or history of allergy or anaphylaxis of any kind.
- Diagnosed with Type 2 diabetes.
- Vegans/vegetarians.
- Consuming protein, amino acid, or creatine supplements; occasional or infrequent use (1 serving per week or less) is allowed.
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 |
|---|---|---|
| Whey Protein SupplementationParticipants will receive Nutrasumma 100% Whey Protein Isolate (unflavored), providing 20 g whey protein isolate per serving. The 20 g of protein from the shake will count toward the total daily protein goal of 1.2 g/kg lean body mass/day. The remaining protein target will be met through the participant's usual diet. | Dietary supplement | Protein Supplementation + Mixed Spices, Protein Supplementation + Placebo |
| Maltodextrin Placebo CapsulesParticipants will consume placebo capsules containing 4 g of maltodextrin daily for 6 months. | Dietary supplement | Protein Supplementation + Placebo |
| Mixed Spice CapsulesParticipants will consume 4 g of mixed spice capsules daily for 6 months. The daily mixture contains 1.0 g turmeric, 1.5 g cinnamon, 0.5 g oregano, 0.5 g black pepper, 0.3 g sage, and 0.2 g thyme. | Dietary supplement | Protein Supplementation + Mixed Spices |
Primary outcome
Change in Muscle Mass Measured by DEXA
Time frame: Baseline, 3 months, and 6 months
Muscle mass will be assessed using dual-energy X-ray absorptiometry (DEXA). Change in muscle mass from baseline to 6 months will be compared among the three study groups.
Change in Muscle Mass Measured by D3-Creatine Enrichment
Time frame: Baseline and 6 months
Muscle mass will be assessed using the D3-creatine (D3Cr) dilution method. Change in muscle mass from baseline to 6 months will be compared among the three study groups. Urinary D3-creatine enrichment will be measured by liquid chromatography with tandem mass spectrometry and used to estimate total body skeletal muscle mass.
18 secondary outcomes
Change in 400-Meter Walk Test Performance
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Stair Climbing Test Performance
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Grip Strength
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Mitochondrial Function
Time frame: Baseline, 3 months, and 6 months
Change in Fasting Glucose
Time frame: Baseline, 3 months, and 6 months
Change in Fasting Insulin
Time frame: Time Frame: Baseline to 6 months
Change in C-Peptide
Time frame: Baseline, 3 months, and 6 months
Change in Glucagon
Time frame: Baseline, 3 months, and 6 months
Change in Glucose-Dependent Insulinotropic Polypeptide (GIP)
Time frame: Baseline, 3 months, and 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Time Frame: Baseline, 3 months, and 6 months
Change in Body Weight
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Body Composition by Bioelectrical Impedance Analysis
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Fatigue Assessed by PROMIS Fatigue Short Form 8a
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Quality of Life Assessed by SF-36
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Dietary Energy and Macronutrient Intake
Time frame: Baseline, 1 month, 3 months, 4.5 months, and 6 months
Change in Physical Activity
Time frame: Baseline, 1 month, 3 months, 4.5 months, and 6 months
Change in Gut Microbiome Composition
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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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.
Zhaoping Li principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Supplementation and Mixed Spice Capsules in people with Obesity & Overweight and Muscle Mass and Strength, run by University of California, Los Angeles 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 4 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Zelicha, PhD, MS, RD (310-206-8292, uclanutrition@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Mass Measured by DEXA (time frame: Baseline, 3 months, and 6 months). The study lists 2 primary outcomes in all. 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 8 Sep 2026.