OsteopeniaNCT07056322
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
A study testing 200 ml dairy, 100 ml milk and 100 g banana in people with Osteopenia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate whether different types of small meals can help reduce bone loss in postmenopausal women with osteopenia, a condition where bone density is lower than normal and may lead to osteoporosis. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- 200 ml dairy, 100 ml milk and 100 g banana
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2025to May 2027
- 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Osteopenia at the lumbar spine defined as BMD t-score -2.4 to -1.1.
- Postmenopausal women
- Age < 80 years
- CTX level ≥ 0.40 ng/ml
- BMI 17-25 kg/m2
Who cannot join
- A diagnosis of osteoporosis, diabetes, primary hyperparathyroidism or active malignancy.
- Current or recent (within two years) use of systemic glucocorticoids for 4 continuous weeks or more, anticonvulsants or anti-osteoporotic drugs including systemic estrogen treatment.
- Low p-25-OH vitamin D-levels (< 50 pmol/l)
- Estimated glomerular filtration (eGFR) <60 ml/min
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus N, 8200
About this study
The goal of this clinical trial is to investigate whether different types of small meals can help reduce bone loss in postmenopausal women with osteopenia, a condition where bone density is lower than normal and may lead to osteoporosis.
The main hypothesis is:
Read more
- A small amount of dairy (100 ml) is just as effective as a larger meal containing dairy and banana in reducing bone resorption.
Based on this, the study aims to answer the following questions:
- Which type and size of meal is most effective in reducing bone resorption?
Researchers will compare five different types of meals to a fasting control day to determine which meals best reduce markers of bone loss in the blood.
Participants will attend six clinical visits: five involving the intake of different test meals, and one control visit involving fasting. The participants will have blood samples taken over a period of 6 hours after each meal or fasting period to measure markers of bone metabolism.
This study aims to identify a simple, non-drug-based strategy to support bone health and help prevent progression to osteoporosis.
Read the detailed description
This project investigates whether administration of a meal can reduce bone resorption and thereby, if used strategic, prevent the development of osteoporosis in postmenopausal women with osteopenia, as measured by bone turnover markers and bone density. Furthermore, it is investigated which type and size of meal is optimal for bone health in osteopenia.
The project comprises of one hypotheses:
- 100 ml dairy is as effective as larger amounts of dairy and banana in decreasing bone resorption.
Osteopenia is a prevalent condition and is a precursor to osteoporosis and fractures. In 2011 it is estimated that osteoporotic fractures resulted a total cost of 1.6 billion EUR in Denmark. Osteopenia is diagnosed by a low bone mineral density (BMD), with a T-score between -1.1 and - 2.4, whereas osteoporosis is diagnosed by a T-score of ≤2.5. In postmenopausal women, it is estimated that 43 % have osteopenia. The current recommendation to prevent fractures in osteopenia is sufficient intake of vitamin D and calcium, besides smoking cessation, physical activity, and moderate alcohol intake. In case of osteoporosis, additional anti-osteoporotic medications are recommended, which have been shown to reduce fracture rates. However, effective non-pharmacologic remedies to prevent progression from osteopenia to osteoporosis are urgently needed and the potential of timing of meals in this context should therefore be explored. Osteopenia and osteoporosis are caused by an increased bone resorption to bone formation ratio which decreases BMD and increases fractures. During the bone resorption and bone formation phases; products are released to the bloodstream and can be measured as bone turnover markers. Carboxy-terminal collagen crosslinks (CTX) is a bone resorption marker and procollagen type I Npropeptide (P1NP) is a bone formation marker and they are internationally recommended as the standard bone turnover markers. Following a meal, bone resorption decreases. The gut hormone; glucagon-like peptide 2 (GLP-2) is released to the circulation following a meal and reduces bone resorption, as measured by CTX, by 50 %. In humans bone resorption is highly increased during the night time (fasting state) and gut hormones have therefore been suggested as treatments for osteoporosis. In a previous study, GLP-2 was administered subcutaneously before bedtime for 120 days and showed a decrease in nightly CTX levels and an increase in bone mineral density at the hip and no signs of tachyphylaxis during the treatment. The investigators have shown that a meal suppresses CTX levels for as long as six hours with a simultaneous increase in GLP-2 and that the oral administration of nutrients is essential for a reduction in CTX. The investigators have great experience in conducting clinical trials assessing bone health. In this project it is investigated which type and size of meals reduce CTX most profoundly.
The meals in this study are selected as 3.5 % fatty dairy or banana as these are commonly used smaller meals. Furthermore, the gastric emptying of a dairy depends on the meal size, and fat reduces the gastric emptying, whereas banana contains fibers and may thus have a shorter gastric emptying. Yoghurt is expected to have slower gastric emptying than milk primarily due to its higher viscosity. Additionally yoghurt is a more fermented product compared to milk, potentially affecting the postprandial gut hormone response differently. Psyllium and banana (pectin fibers) are both dietary fiber sources but differ in fiber composition and solubility, which may lead to different effects on gastric emptying and gut hormone responses. The fiber content differs between banana and psyllium, with psyllium being more concentrated. We aim to adjust the fiber content to be approximately equivalent, so participants will receive 4-5 g of psyllium (1 teaspoon), providing about the same amount of fiber as 100 g of banana.
The results from this study will be used for a follow up study in which the effects on bone health of meal administration over a longer period will be assessed.
- Conditions
- Osteopenia
- Being tested
- 200 ml dairy, 100 ml milk, 100 g banana, 100 ml dairy and fibers, Fasting (control)
- Keywords
- Osteopenia, Meal intervention, Bone turnover
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 ml dairyDietary supplement
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
100 ml milkDietary supplement
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
100 g bananaDietary supplement
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
100 ml dairy and fibersDietary supplement
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
Fasting (control)Other
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
100 ml dairyDietary supplement
Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers.
| Study group | Role | What they receive |
|---|---|---|
| Meals or fasting in randomized order | Experimental | All participants will receive each of the six interventions (five different meals and one fasting control) in randomized order, with a minimum 1 week washout between test days. The order of the interventions is individually randomized. Blood samples will be collected at arrival and hourly during each visit to assess bone turnover markers. Receives: Dietary Supplement: 200 ml dairy; Dietary Supplement: 100 ml milk; Dietary Supplement: 100 g banana; Dietary Supplement: 100 ml dairy and fibers; Other: Fasting (control); Dietary Supplement: 100 ml dairy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone resoroption
The primary endpoint of the study is difference in the area under curve of the bone resorption marker CTX during the different study days
Measured: From enrollment through six study visits over a period of approximately 12 weeks
Secondary outcomes (4)
Change in bone formation marker P1NP
Secondary outcome assesing changes in the bone formation marker P1NP
Measured: From enrollment through six study visits over a period of approximately 12 weeks
Changes in osteocalcin levels
Secondary outcome assesing changes in the bone turnover marker osteocalcin
Measured: From enrollment through six study visits over a period of approximately 12 weeks
Changes in immune respons (Treg/Th17 cell ratio)
Secondary outcome assesing changes in the immune cell composition (Treg/Th17 cell ratio)
Measured: From enrollment through six study visits over a period of approximately 12 weeks
Changes in the incretin hormone GLP-2
Secondary outcome assesing changes in levels of GLP-2
Measured: From enrollment through six study visits over a period of approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- The cross-over trial study consists of six study days, where the women in random order at 08.00 are administered a) 100 ml yoghurt natural b) 200 ml yoghurt natural, c) 100 ml of milk, d) 100 g banana e) dairy and fibers, and f) fasting. The participants will meet at 07.00 on the study days after an overnight fast. 24 hours before the study days the participants are asked to refrain from exercise and alcohol. During the study days blood samples are collected from an intravenous access hourly from 08.00 until 14.00 to measure changes in bone turnover markers and gut hormones.
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob S Linde, Medical Doctor, MD, PhD, Principal investigator, Department of Endocrinology and Internal Medicine, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056322
- Sponsor's protocol ID
- OsteoMeal-study1
- Other IDs
- PhD030-24
- Status last verified
- Nov 2026
- First submitted
- 27 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giuntini EB, Sarda FAH, de Menezes EW. The Effects of Soluble Dietary Fibers on Glycemic Response: An Overview and Futures Perspectives. Foods. 2022 Dec 6;11(23):3934. doi: 10.3390/foods11233934.
PubMed 36496742Weber AM, Pascale N, Gu F, Ryan EP, Respondek F. Nutrition and health effects of pectin: A systematic scoping review of human intervention studies. Nutr Res Rev. 2025 Jun;38(1):306-323. doi: 10.1017/S0954422424000180. Epub 2024 Sep 26.
PubMed 39324277Sanggaard KM, Holst JJ, Rehfeld JF, Sandstrom B, Raben A, Tholstrup T. Different effects of whole milk and a fermented milk with the same fat and lactose content on gastric emptying and postprandial lipaemia, but not on glycaemic response and appetite. Br J Nutr. 2004 Sep;92(3):447-59. doi: 10.1079/bjn20041219.
PubMed 15469648Menard O, Famelart MH, Deglaire A, Le Gouar Y, Guerin S, Malbert CH, Dupont D. Gastric Emptying and Dynamic In Vitro Digestion of Drinkable Yogurts: Effect of Viscosity and Composition. Nutrients. 2018 Sep 14;10(9):1308. doi: 10.3390/nu10091308.
PubMed 30223532Berry SD, McLean RR, Hannan MT, Cupples LA, Kiel DP. Changes in bone mineral density may predict the risk of fracture differently in older adults according to fall history. J Am Geriatr Soc. 2014 Dec;62(12):2345-9. doi: 10.1111/jgs.13127. Epub 2014 Nov 29.
PubMed 25438807Sayon-Orea C, Martinez-Gonzalez MA, Ruiz-Canela M, Bes-Rastrollo M. Associations between Yogurt Consumption and Weight Gain and Risk of Obesity and Metabolic Syndrome: A Systematic Review. Adv Nutr. 2017 Jan 17;8(1):146S-154S. doi: 10.3945/an.115.011536. Print 2017 Jan.
PubMed 28096138Miller KC. Plasma potassium concentration and content changes after banana ingestion in exercised men. J Athl Train. 2012 Nov-Dec;47(6):648-54. doi: 10.4085/1062-6050-47.6.05.
PubMed 23182013Keszthelyi D, Knol D, Troost FJ, van Avesaat M, Foltz M, Masclee AA. Time of ingestion relative to meal intake determines gastrointestinal responses to a plant sterol-containing yoghurt drink. Eur J Nutr. 2013 Jun;52(4):1417-20. doi: 10.1007/s00394-012-0440-3. Epub 2012 Aug 23.
PubMed 22915051Starup-Linde J, Ornstrup MJ, Kjaer TN, Lykkeboe S, Handberg A, Gregersen S, Harslof T, Pedersen SB, Vestergaard P, Langdahl BL. Bone Density and Structure in Overweight Men With and Without Diabetes. Front Endocrinol (Lausanne). 2022 Mar 10;13:837084. doi: 10.3389/fendo.2022.837084. eCollection 2022.
PubMed 35360074Fuglsang-Nielsen R, Rakvaag E, Vestergaard P, Hermansen K, Gregersen S, Starup-Linde J. The Effects of 12-Weeks Whey Protein Supplements on Markers of Bone Turnover in Adults With Abdominal Obesity - A Post Hoc Analysis. Front Endocrinol (Lausanne). 2022 Mar 29;13:832897. doi: 10.3389/fendo.2022.832897. eCollection 2022.
PubMed 35422766Veldhuis-Vlug AG, Rosen CJ. Mechanisms of marrow adiposity and its implications for skeletal health. Metabolism. 2017 Feb;67:106-114. doi: 10.1016/j.metabol.2016.11.013. Epub 2016 Nov 27.
PubMed 28081773Westberg-Rasmussen S, Starup-Linde J, Hermansen K, Holst JJ, Hartmann B, Vestergaard P, Gregersen S. Differential impact of glucose administered intravenously or orally on bone turnover markers in healthy male subjects. Bone. 2017 Apr;97:261-266. doi: 10.1016/j.bone.2017.01.027. Epub 2017 Jan 23.
PubMed 28126633Henriksen DB, Alexandersen P, Hartmann B, Adrian CL, Byrjalsen I, Bone HG, Holst JJ, Christiansen C. Four-month treatment with GLP-2 significantly increases hip BMD: a randomized, placebo-controlled, dose-ranging study in postmenopausal women with low BMD. Bone. 2009 Nov;45(5):833-42. doi: 10.1016/j.bone.2009.07.008. Epub 2009 Jul 22.
PubMed 19631303Bjarnason NH, Henriksen EE, Alexandersen P, Christgau S, Henriksen DB, Christiansen C. Mechanism of circadian variation in bone resorption. Bone. 2002 Jan;30(1):307-13. doi: 10.1016/s8756-3282(01)00662-7.
PubMed 11792602Bjornshave A, Lykkeboe S, Hartmann B, Holst JJ, Hermansen K, Starup-Linde J. Effects of a whey protein pre-meal on bone turnover in participants with and without type 2 diabetes-A post hoc analysis of a randomised, controlled, crossover trial. Diabet Med. 2021 Jun;38(6):e14471. doi: 10.1111/dme.14471. Epub 2020 Dec 13.
PubMed 33259643
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
- ClinicalTrials.gov ID
- NCT07056322
- Acronym / sponsor ID
- OsteoMeal-study1
- Conditions
- Osteopenia
- Keywords
- Osteopenia, Meal intervention, Bone turnover
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Jul 2025 (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.
The goal of this clinical trial is to investigate whether different types of small meals can help reduce bone loss in postmenopausal women with osteopenia, a condition where bone density is lower than normal and may lead to osteoporosis.
The main hypothesis is:
- A small amount of dairy (100 ml) is just as effective as a larger meal containing dairy and banana in reducing bone resorption.
Based on this, the study aims to answer the following questions:
- Which type and size of meal is most effective in reducing bone resorption?
Researchers will compare five different types of meals to a fasting control day to determine which meals best reduce markers of bone loss in the blood.
Participants will attend six clinical visits: five involving the intake of different test meals, and one control visit involving fasting. The participants will have blood samples taken over a period of 6 hours after each meal or fasting period to measure markers of bone metabolism.
This study aims to identify a simple, non-drug-based strategy to support bone health and help prevent progression to osteoporosis.
Detailed description
This project investigates whether administration of a meal can reduce bone resorption and thereby, if used strategic, prevent the development of osteoporosis in postmenopausal women with osteopenia, as measured by bone turnover markers and bone density. Furthermore, it is investigated which type and size of meal is optimal for bone health in osteopenia.
The project comprises of one hypotheses:
- 100 ml dairy is as effective as larger amounts of dairy and banana in decreasing bone resorption.
Osteopenia is a prevalent condition and is a precursor to osteoporosis and fractures. In 2011 it is estimated that osteoporotic fractures resulted a total cost of 1.6 billion EUR in Denmark. Osteopenia is diagnosed by a low bone mineral density (BMD), with a T-score between -1.1 and - 2.4, whereas osteoporosis is diagnosed by a T-score of ≤2.5. In postmenopausal women, it is estimated that 43 % have osteopenia. The current recommendation to prevent fractures in osteopenia is sufficient intake of vitamin D and calcium, besides smoking cessation, physical activity, and moderate alcohol intake. In case of osteoporosis, additional anti-osteoporotic medications are recommended, which have been shown to reduce fracture rates. However, effective non-pharmacologic remedies to prevent progression from osteopenia to osteoporosis are urgently needed and the potential of timing of meals in this context should therefore be explored. Osteopenia and osteoporosis are caused by an increased bone resorption to bone formation ratio which decreases BMD and increases fractures. During the bone resorption and bone formation phases; products are released to the bloodstream and can be measured as bone turnover markers. Carboxy-terminal collagen crosslinks (CTX) is a bone resorption marker and procollagen type I Npropeptide (P1NP) is a bone formation marker and they are internationally recommended as the standard bone turnover markers. Following a meal, bone resorption decreases. The gut hormone; glucagon-like peptide 2 (GLP-2) is released to the circulation following a meal and reduces bone resorption, as measured by CTX, by 50 %. In humans bone resorption is highly increased during the night time (fasting state) and gut hormones have therefore been suggested as treatments for osteoporosis. In a previous study, GLP-2 was administered subcutaneously before bedtime for 120 days and showed a decrease in nightly CTX levels and an increase in bone mineral density at the hip and no signs of tachyphylaxis during the treatment. The investigators have shown that a meal suppresses CTX levels for as long as six hours with a simultaneous increase in GLP-2 and that the oral administration of nutrients is essential for a reduction in CTX. The investigators have great experience in conducting clinical trials assessing bone health. In this project it is investigated which type and size of meals reduce CTX most profoundly.
The meals in this study are selected as 3.5 % fatty dairy or banana as these are commonly used smaller meals. Furthermore, the gastric emptying of a dairy depends on the meal size, and fat reduces the gastric emptying, whereas banana contains fibers and may thus have a shorter gastric emptying. Yoghurt is expected to have slower gastric emptying than milk primarily due to its higher viscosity. Additionally yoghurt is a more fermented product compared to milk, potentially affecting the postprandial gut hormone response differently. Psyllium and banana (pectin fibers) are both dietary fiber sources but differ in fiber composition and solubility, which may lead to different effects on gastric emptying and gut hormone responses. The fiber content differs between banana and psyllium, with psyllium being more concentrated. We aim to adjust the fiber content to be approximately equivalent, so participants will receive 4-5 g of psyllium (1 teaspoon), providing about the same amount of fiber as 100 g of banana.
The results from this study will be used for a follow up study in which the effects on bone health of meal administration over a longer period will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The cross-over trial study consists of six study days, where the women in random order at 08.00 are administered a) 100 ml yoghurt natural b) 200 ml yoghurt natural, c) 100 ml of milk, d) 100 g banana e) dairy and fibers, and f) fasting. The participants will meet at 07.00 on the study days after an overnight fast. 24 hours before the study days the participants are asked to refrain from exercise and alcohol. During the study days blood samples are collected from an intravenous access hourly from 08.00 until 14.00 to measure changes in bone turnover markers and gut hormones.
| Arm | Type | Receives |
|---|---|---|
| Meals or fasting in randomized order | Experimental | Dietary Supplement: 200 ml dairy, Dietary Supplement: 100 ml milk, Dietary Supplement: 100 g banana, Dietary Supplement: 100 ml dairy and fibers, Other: Fasting (control), Dietary Supplement: 100 ml dairyAll participants will receive each of the six interventions (five different meals and one fasting control) in randomized order, with a minimum 1 week washout between test days. The order of the interventions is individually randomized. Blood samples will be collected at arrival and hourly during each visit to assess bone turnover markers. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Osteopenia at the lumbar spine defined as BMD t-score -2.4 to -1.1.
- Postmenopausal women
- Age < 80 years
- CTX level ≥ 0.40 ng/ml
- BMI 17-25 kg/m2
Key exclusion criteria (4 listed)
- A diagnosis of osteoporosis, diabetes, primary hyperparathyroidism or active malignancy.
- Current or recent (within two years) use of systemic glucocorticoids for 4 continuous weeks or more, anticonvulsants or anti-osteoporotic drugs including systemic estrogen treatment.
- Low p-25-OH vitamin D-levels (< 50 pmol/l)
- Estimated glomerular filtration (eGFR) <60 ml/min
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 |
|---|---|---|
| 200 ml dairyParticipants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Dietary supplement | Meals or fasting in randomized order |
| 100 ml milkParticipants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Dietary supplement | Meals or fasting in randomized order |
| 100 g bananaParticipants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Dietary supplement | Meals or fasting in randomized order |
| 100 ml dairy and fibersParticipants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Dietary supplement | Meals or fasting in randomized order |
| Fasting (control)Participants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Other | Meals or fasting in randomized order |
| 100 ml dairyParticipants consume the meal after a fasting baseline bloodsample. Bloodsamples are collected over a six-hour period to evaluate postpandrial changes in bone turnover markers. | Dietary supplement | Meals or fasting in randomized order |
Primary outcome
Bone resoroption
Time frame: From enrollment through six study visits over a period of approximately 12 weeks
The primary endpoint of the study is difference in the area under curve of the bone resorption marker CTX during the different study days
4 secondary outcomes
Change in bone formation marker P1NP
Time frame: From enrollment through six study visits over a period of approximately 12 weeks
Changes in osteocalcin levels
Time frame: From enrollment through six study visits over a period of approximately 12 weeks
Changes in immune respons (Treg/Th17 cell ratio)
Time frame: From enrollment through six study visits over a period of approximately 12 weeks
Changes in the incretin hormone GLP-2
Time frame: From enrollment through six study visits over a period of approximately 12 weeks
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 4 Nov 2026.
- Background: PubMed 36496742Giuntini EB, Sarda FAH, de Menezes EW. The Effects of Soluble Dietary Fibers on Glycemic Response: An Overview and Futures Perspectives. Foods. 2022 Dec 6;11(23):3934. doi: 10.3390/foods11233934.
- Background: PubMed 39324277Weber AM, Pascale N, Gu F, Ryan EP, Respondek F. Nutrition and health effects of pectin: A systematic scoping review of human intervention studies. Nutr Res Rev. 2025 Jun;38(1):306-323. doi: 10.1017/S0954422424000180. Epub 2024 Sep 26.
- Background: PubMed 15469648Sanggaard KM, Holst JJ, Rehfeld JF, Sandstrom B, Raben A, Tholstrup T. Different effects of whole milk and a fermented milk with the same fat and lactose content on gastric emptying and postprandial lipaemia, but not on glycaemic response and appetite. Br J Nutr. 2004 Sep;92(3):447-59. doi: 10.1079/bjn20041219.
- Background: PubMed 30223532Menard O, Famelart MH, Deglaire A, Le Gouar Y, Guerin S, Malbert CH, Dupont D. Gastric Emptying and Dynamic In Vitro Digestion of Drinkable Yogurts: Effect of Viscosity and Composition. Nutrients. 2018 Sep 14;10(9):1308. doi: 10.3390/nu10091308.
- Background: PubMed 25438807Berry SD, McLean RR, Hannan MT, Cupples LA, Kiel DP. Changes in bone mineral density may predict the risk of fracture differently in older adults according to fall history. J Am Geriatr Soc. 2014 Dec;62(12):2345-9. doi: 10.1111/jgs.13127. Epub 2014 Nov 29.
- Background: PubMed 28096138Sayon-Orea C, Martinez-Gonzalez MA, Ruiz-Canela M, Bes-Rastrollo M. Associations between Yogurt Consumption and Weight Gain and Risk of Obesity and Metabolic Syndrome: A Systematic Review. Adv Nutr. 2017 Jan 17;8(1):146S-154S. doi: 10.3945/an.115.011536. Print 2017 Jan.
- Background: PubMed 23182013Miller KC. Plasma potassium concentration and content changes after banana ingestion in exercised men. J Athl Train. 2012 Nov-Dec;47(6):648-54. doi: 10.4085/1062-6050-47.6.05.
- Background: PubMed 22915051Keszthelyi D, Knol D, Troost FJ, van Avesaat M, Foltz M, Masclee AA. Time of ingestion relative to meal intake determines gastrointestinal responses to a plant sterol-containing yoghurt drink. Eur J Nutr. 2013 Jun;52(4):1417-20. doi: 10.1007/s00394-012-0440-3. Epub 2012 Aug 23.
- Background: PubMed 35360074Starup-Linde J, Ornstrup MJ, Kjaer TN, Lykkeboe S, Handberg A, Gregersen S, Harslof T, Pedersen SB, Vestergaard P, Langdahl BL. Bone Density and Structure in Overweight Men With and Without Diabetes. Front Endocrinol (Lausanne). 2022 Mar 10;13:837084. doi: 10.3389/fendo.2022.837084. eCollection 2022.
- Background: PubMed 35422766Fuglsang-Nielsen R, Rakvaag E, Vestergaard P, Hermansen K, Gregersen S, Starup-Linde J. The Effects of 12-Weeks Whey Protein Supplements on Markers of Bone Turnover in Adults With Abdominal Obesity - A Post Hoc Analysis. Front Endocrinol (Lausanne). 2022 Mar 29;13:832897. doi: 10.3389/fendo.2022.832897. eCollection 2022.
- Background: PubMed 28081773Veldhuis-Vlug AG, Rosen CJ. Mechanisms of marrow adiposity and its implications for skeletal health. Metabolism. 2017 Feb;67:106-114. doi: 10.1016/j.metabol.2016.11.013. Epub 2016 Nov 27.
- Background: PubMed 28126633Westberg-Rasmussen S, Starup-Linde J, Hermansen K, Holst JJ, Hartmann B, Vestergaard P, Gregersen S. Differential impact of glucose administered intravenously or orally on bone turnover markers in healthy male subjects. Bone. 2017 Apr;97:261-266. doi: 10.1016/j.bone.2017.01.027. Epub 2017 Jan 23.
- Individual participant dataSharing planned: Undecided
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
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.
Jakob S Linde, Medical Doctor, MD, PhD principal investigator
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 ml dairy, 100 ml milk and 100 g banana in people with Osteopenia, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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 Denmark. 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?
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?
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?
Bone resoroption (time frame: From enrollment through six study visits over a period of approximately 12 weeks). 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 NCT07056322, which also lists 19 linked publications.
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 4 Nov 2026.