Optimal Meals to Reduce Bone Resorption in Women With Osteopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Milk Protein and Bone Health in Postmenopausal Women

NCT03701113

Bone and Bones Osteoporosis Risk Osteoporosis, Postmenopausal

COMPLETED NA

Nutritional Supplement and Bone Health in Post-Menopausal Women

NCT03337971

Bone and Bones Osteoporosis Risk Osteoporosis, Postmenopausal

COMPLETED NA

The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia

NCT06358443

Osteopenia Osteoporosis

COMPLETED NA

Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

NCT01478724

Osteoporosis

COMPLETED PHASE1

Profylactic Treatment for Patients in Risk Osteoporosis

NCT05787808

Osteopenia or Osteoporosis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Osteopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meals or fasting in randomized order

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.

Group Type EXPERIMENTAL