Dairy ProductsNCT06412302
High Protein Dairy Products and Resistance Exercise in the Elderly
A study testing Whey Protein+Resistance Training and High protein yogurt+Resistance Training in people with Dairy Products and Whey Protein, run by Universidad de O´Higgins at 1 site in Chile.
Trial summary
Protein supplementation is one of the main recommendations for regular endurance physical exercise (RT). In older people, the need for protein increases particularly in the face of physiological and pathophysiological changes associated with the loss of muscle tissue and function, so protein intake becomes more… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dairy Products, Whey Protein, Resistance Training
- What is being tested?
- Whey Protein+Resistance Training and High protein yogurt+Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2023to 12 Jan 2024
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >60 years
- Less than 1 hour of exercise a week
Who cannot join
- Lactose Intolerant
- Smoking
- Type 1 or 2 Diabetes
- Alcohol intake
- Currently taking protein, high protein yogurts, creatine, HMB or any other supplement that aims to improve muscle mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No-Whey: High Protein Dairy and Resistance Exercise for the Improvement of Body Composition and Muscle Function in the Elderly
Protein supplementation is one of the main recommendations for regular endurance physical exercise (RT). In older people, the need for protein increases particularly in the face of physiological and pathophysiological changes associated with the loss of muscle tissue and function, so protein intake becomes more relevant in this population. Fermented dairy products such as yogurt, and especially those with an extra protein content, have increased their popularity and consumption in the national market. Their nutritional composition is of particular interest, given their amino acid profile and in particular their high Leucine content, which could be compared with the classic protein supplements recommended for muscle gain and recovery. Objective: To analyze the effect on body composition, lipid profile, physical condition and muscle functionality induced by the intake of high protein yogurts versus Whey protein together with a muscular resistance program in elderly people. Hypothesis: The intake of high protein yogurts will lead to equal or greater gains in muscle mass, physical condition and functionality than those obtained with the intake of Whey protein together with resistance training in elderly people.Methodology: 16 healthy, lactose intolerant free, older (60-75 years old) subjects will be recruited to perform 8 weeks of muscular resistance training (RT) 3 times per week, who will be randomly supplemented with high protein yogurt (PY) or Whey protein (WP). At baseline and at the end of the intervention, body composition will be assessed by DEXA, muscle strength, maximal oxygen consumption and lipid profile. Expected Results: The YPRT group is expected to achieve similar or greater increases in muscle strength, fat-free mass, lipid profile and decrease in fat mass than the WP group.
- Conditions
- Dairy Products, Whey Protein, Resistance Training, Older Adults
- Being tested
- Whey Protein+Resistance Training, High protein yogurt+Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein+Resistance TrainingOther
Also called WP
WP group received 25g protein on one scoop of Whey Protein Isolate (Iso100 Dymatize) with 8 weeks of resistance training 3 days a week.
High protein yogurt+Resistance TrainingOther
Also called PY
PY group received 24.6g protein on two High Protein yogurts (Lonco Leche) with 8 weeks of resistance training 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein+Resistance Training | Experimental | Participants will undergo 8 weeks of resistance training and receive a whey protein shake after each exercise session. Receives: Other: Whey Protein+Resistance Training |
| Protein Yogurt+Resistance Training | Experimental | Participants will undergo 8 weeks of resistance training and receive a yogurt shake after each exercise session. Receives: Other: High protein yogurt+Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Changes in weight, total fat mass, total skeletal muscle mass, segmental fat and muscle mass
Measured: From Baseline, up to 56 days
Blood Lipids
Changes on Serum Triglycerides, Total Cholesterol, and High Density Cholesterol (mmol/L)
Measured: From Baseline, up to 56 days
Muscle Strength
Determine by Isometric mid-tight pull (Newton, N)
Measured: From Baseline, up to 56 days
Handgrip
Handgrip Strength measured on left and right hand (kg)
Measured: From Baseline, up to 56 days
Time Up and Go
Length of time from sitting-walk-sit (seconds)
Measured: From Baseline, up to 56 days
Isokinetic Muscle Strength
Maximal peak torque from left and right quadriceps and hamstrings (N/m)
Measured: From Baseline, up to 56 days
Aerobic Capacity
Maximal Oxygen Consumption determine by the volume of oxygen (L/min)obtained on a incremental test
Measured: From Baseline, up to 56 days
Resting Metabolic Rate
Determine by indirect calorimetry (kcal/d)
Measured: From Baseline, up to 56 days
Evaluation of the intestinal microbiota
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
Measured: From Baseline, up to 56 days
Secondary outcomes (2)
Food Consumption
24h food recall
Measured: From Baseline, up to 56 days
Evaluation of liver characteristics profile
Uric acid, BUN, Albumin, Creatinine aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (GGT) after every intervention and wash-out in plasma (mmol/L).
Measured: From Baseline, up to 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jun 2023
- Primary completion25 Sep 2023
- Study completion12 Jan 2024
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 Dairy ProductsStudies 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
- The PY group will be provided with two yogurts and 50 of water (220g per serving, containing 24.6g protein, 1.4g fat, and 16.6 carbohydrates), while the WP will be provided with a shake with water (25g per serving containing; 25g protein, 0g fat, and 1g carbohydrates, dissolved in water), immediately after the exercise session which a trainer will monitor. Both groups will submit to a resistance training group every 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de O´Higgins
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos, Geroscience Center for Brain Health and Metabolism (Gero), Motion Health and Performance Center
- Responsible party
- Principal investigator, Matias Monsalves Álvarez, Universidad de O´Higgins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412302
- Sponsor's protocol ID
- 027-2023
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monsalves-Alvarez M, Calderon-Romero P, Hayes-Ortiz T, Bobadilla S, Sanchez F, de Tudela CP, Utreras-Mendoza Y, Campos C, Reyes A, Gomez J, Zara B, Sepulveda C, Troncoso R, Correa-Burrows P, Gonzales-Billault C, Court FA, Flores-Opazo M, Valladares-Ide D. Protein yogurt and whey protein produce comparable muscle gains, but divergent microbiome shifts during strength training in older adults. Sci Rep. 2026 May 18;16(1):22592. doi: 10.1038/s41598-026-51209-3.
PubMed 42151371
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-Whey: High Protein Dairy and Resistance Exercise for the Improvement of Body Composition and Muscle Function in the Elderly
- ClinicalTrials.gov ID
- NCT06412302
- Acronym / sponsor ID
- 027-2023
- Conditions
- Dairy Products, Whey Protein, Resistance Training, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad de O´HigginsUniversity, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos, Geroscience Center for Brain Health and Metabolism (Gero), Motion Health and Performance Center
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 14 May 2024 (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.
Protein supplementation is one of the main recommendations for regular endurance physical exercise (RT). In older people, the need for protein increases particularly in the face of physiological and pathophysiological changes associated with the loss of muscle tissue and function, so protein intake becomes more relevant in this population. Fermented dairy products such as yogurt, and especially those with an extra protein content, have increased their popularity and consumption in the national market. Their nutritional composition is of particular interest, given their amino acid profile and in particular their high Leucine content, which could be compared with the classic protein supplements recommended for muscle gain and recovery. Objective: To analyze the effect on body composition, lipid profile, physical condition and muscle functionality induced by the intake of high protein yogurts versus Whey protein together with a muscular resistance program in elderly people. Hypothesis: The intake of high protein yogurts will lead to equal or greater gains in muscle mass, physical condition and functionality than those obtained with the intake of Whey protein together with resistance training in elderly people.Methodology: 16 healthy, lactose intolerant free, older (60-75 years old) subjects will be recruited to perform 8 weeks of muscular resistance training (RT) 3 times per week, who will be randomly supplemented with high protein yogurt (PY) or Whey protein (WP). At baseline and at the end of the intervention, body composition will be assessed by DEXA, muscle strength, maximal oxygen consumption and lipid profile. Expected Results: The YPRT group is expected to achieve similar or greater increases in muscle strength, fat-free mass, lipid profile and decrease in fat mass than the WP group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The PY group will be provided with two yogurts and 50 of water (220g per serving, containing 24.6g protein, 1.4g fat, and 16.6 carbohydrates), while the WP will be provided with a shake with water (25g per serving containing; 25g protein, 0g fat, and 1g carbohydrates, dissolved in water), immediately after the exercise session which a trainer will monitor. Both groups will submit to a resistance training group every 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Whey Protein+Resistance Training | Experimental | Other: Whey Protein+Resistance TrainingParticipants will undergo 8 weeks of resistance training and receive a whey protein shake after each exercise session. |
| Protein Yogurt+Resistance Training | Experimental | Other: High protein yogurt+Resistance TrainingParticipants will undergo 8 weeks of resistance training and receive a yogurt shake after each exercise session. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >60 years
- Less than 1 hour of exercise a week
Key exclusion criteria (5 listed)
- Lactose Intolerant
- Smoking
- Type 1 or 2 Diabetes
- Alcohol intake
- Currently taking protein, high protein yogurts, creatine, HMB or any other supplement that aims to improve muscle mass
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+Resistance TrainingAlso: WPWP group received 25g protein on one scoop of Whey Protein Isolate (Iso100 Dymatize) with 8 weeks of resistance training 3 days a week. | Other | Whey Protein+Resistance Training |
| High protein yogurt+Resistance TrainingAlso: PYPY group received 24.6g protein on two High Protein yogurts (Lonco Leche) with 8 weeks of resistance training 3 days a week. | Other | Protein Yogurt+Resistance Training |
Primary outcome
Body Composition
Time frame: From Baseline, up to 56 days
Changes in weight, total fat mass, total skeletal muscle mass, segmental fat and muscle mass
Blood Lipids
Time frame: From Baseline, up to 56 days
Changes on Serum Triglycerides, Total Cholesterol, and High Density Cholesterol (mmol/L)
Muscle Strength
Time frame: From Baseline, up to 56 days
Determine by Isometric mid-tight pull (Newton, N)
Handgrip
Time frame: From Baseline, up to 56 days
Handgrip Strength measured on left and right hand (kg)
Time Up and Go
Time frame: From Baseline, up to 56 days
Length of time from sitting-walk-sit (seconds)
Isokinetic Muscle Strength
Time frame: From Baseline, up to 56 days
Maximal peak torque from left and right quadriceps and hamstrings (N/m)
Aerobic Capacity
Time frame: From Baseline, up to 56 days
Maximal Oxygen Consumption determine by the volume of oxygen (L/min)obtained on a incremental test
Resting Metabolic Rate
Time frame: From Baseline, up to 56 days
Determine by indirect calorimetry (kcal/d)
Evaluation of the intestinal microbiota
Time frame: From Baseline, up to 56 days
Fecal microbiota analysis based on the 16S ribosomal RNA (rRNA) sequencing pre- and post-dietary intervention.
2 secondary outcomes
Food Consumption
Time frame: From Baseline, up to 56 days
Evaluation of liver characteristics profile
Time frame: From Baseline, up to 56 days
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 14 May 2024.
- Derived from this study: PubMed 42151371Monsalves-Alvarez M, Calderon-Romero P, Hayes-Ortiz T, Bobadilla S, Sanchez F, de Tudela CP, Utreras-Mendoza Y, Campos C, Reyes A, Gomez J, Zara B, Sepulveda C, Troncoso R, Correa-Burrows P, Gonzales-Billault C, Court FA, Flores-Opazo M, Valladares-Ide D. Protein yogurt and whey protein produce comparable muscle gains, but divergent microbiome shifts during strength training in older adults. Sci Rep. 2026 May 18;16(1):22592. doi: 10.1038/s41598-026-51209-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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+Resistance Training and High protein yogurt+Resistance Training in people with Dairy Products and Whey Protein, run by Universidad de O´Higgins at 1 site in Chile.
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 2 inclusion and 5 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 14 May 2024. 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 Chile. 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?
Body Composition (time frame: From Baseline, up to 56 days). The study lists 9 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 NCT06412302, 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 14 May 2024.