Optimal Meals to Reduce Bone Resorption in Women With Osteopenia

NCT07056322 | Enrolling By Invitation

• 2 other identifiers: OsteoMeal-study1PhD030-24
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

Osteopenia; Meal intervention; Bone turnover

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment through six study visits over a period of approximately 12 weeks

Secondary Outcomes (4)

• Change in bone formation marker P1NP

  From enrollment through six study visits over a period of approximately 12 weeks

• Changes in osteocalcin levels

  From enrollment through six study visits over a period of approximately 12 weeks

• Changes in immune respons (Treg/Th17 cell ratio)

  From enrollment through six study visits over a period of approximately 12 weeks

• Changes in the incretin hormone GLP-2

  From enrollment through six study visits over a period of approximately 12 weeks

Study Arms (1)

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.

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

Interventions

200 ml dairy DIETARY_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.

Meals or fasting in randomized order

100 ml milk DIETARY_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.

Meals or fasting in randomized order

100 g banana DIETARY_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.

Meals or fasting in randomized order

100 ml dairy and fibers DIETARY_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.

Meals or fasting in randomized order

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.

Meals or fasting in randomized order

100 ml dairy DIETARY_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.

Meals or fasting in randomized order

Eligibility Criteria

• Age: Up to 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (19)

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MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Milk

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Jakob S Linde, Medical Doctor, MD, PhD

  Department of Endocrinology and Internal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinding of participants is not possible, laboratory staff who will analyse the blood samples, will be blinded to the intervention.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-05

Locations

DK (1)