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Optimal Meals to Reduce Bone Resorption in Women With Osteopenia

Optimal Meals to Reduce Bone Resorption in Women With Osteopenia

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07056322
Enrollment
13
Registered
2025-07-09
Start date
2025-12-01
Completion date
2026-10-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

Keywords

Osteopenia, Meal intervention, Bone turnover

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENT200 ml dairy

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.

DIETARY_SUPPLEMENT100 ml milk

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.

DIETARY_SUPPLEMENT100 g banana

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.

DIETARY_SUPPLEMENT100 ml dairy and fibers

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.

OTHERFasting (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.

DIETARY_SUPPLEMENT100 ml dairy

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

Blinding of participants is not possible, laboratory staff who will analyse the blood samples, will be blinded to the intervention.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Bone resoroptionFrom enrollment through six study visits over a period of approximately 12 weeksThe primary endpoint of the study is difference in the area under curve of the bone resorption marker CTX during the different study days

Secondary

MeasureTime frameDescription
Change in bone formation marker P1NPFrom enrollment through six study visits over a period of approximately 12 weeksSecondary outcome assesing changes in the bone formation marker P1NP
Changes in osteocalcin levelsFrom enrollment through six study visits over a period of approximately 12 weeksSecondary outcome assesing changes in the bone turnover marker osteocalcin
Changes in immune respons (Treg/Th17 cell ratio)From enrollment through six study visits over a period of approximately 12 weeksSecondary outcome assesing changes in the immune cell composition (Treg/Th17 cell ratio)
Changes in the incretin hormone GLP-2From enrollment through six study visits over a period of approximately 12 weeksSecondary outcome assesing changes in levels of GLP-2

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORJakob S Linde, Medical Doctor, MD, PhD

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026