Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus-post hoc analysis from a 3-month randomized placebo-controlled trial

Komal Waqas; Mardin Rashid; Bram C.J. Van Der Eerden; Sjoerd A.A. Van Den Berg; Eric J.G. Sijbrands; Kirsten A. Berk; M. Carola Zillikens

doi:10.3233/NHA-220157

Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus-post hoc analysis from a 3-month randomized placebo-controlled trial

Komal Waqas, Mardin Rashid, Bram C.J. Van Der Eerden, Sjoerd A.A. Van Den Berg, Eric J.G. Sijbrands, Kirsten A. Berk, M. Carola Zillikens^*

^*Corresponding author for this work

Internal Medicine

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Individuals with type 2 diabetes mellitus (T2DM) have increased fracture risk with high bone mineral density, possibly related to advanced glycation end products (AGEs) accumulation in bone. Flavanol supplementation in postmenopausal women reduced AGEs formation and decreased bone resorption markers. However, to date, these effects have not been investigated in T2DM. OBJECTIVE: We used a post hoc secondary analysis to determine the effect of monomeric and oligomeric flavanols supplementation on bone turnover markers (BTMs) in individuals with T2DM. METHODS: Eighty-three individuals with T2DM, aged 40-85 years, with microalbuminuria were enrolled from 4 trial centers in Rotterdam, the Netherlands, into a randomized, double-blind, placebo-controlled trial with renal vascular health as the primary outcome. Participants were randomized (1:1) to receive either a placebo or 200 mg of monomeric and oligomeric flavanols as intervention for three months. Serum alkaline phosphatase (ALP), type I collagen crosslinked beta C-telopeptide (β-CTx), and type I procollagen-N-propeptide (P1NP) were measured at baseline and three months. ANCOVA was performed on rank transformed BTMs at three months as the outcome, adjusting for baseline BTMs, group, age, sex, and BMI. RESULTS: Baseline characteristics did not differ between the two arms. The adjusted mean change in BTMs at three months was not different between the placebo vs. intervention arm: ALP -0.059 (-0.262-0.145) vs. 0.060 (-0.135-0.356), p = 0.41; β-CTx 0.013 (-0.205-0.231) vs. 0.100 (-0.109-0.310), p = 0.53 and P1NP 0.091 (-0.080-0.262) vs. 0.030 (-0.134-0.195), p = 0.61. There was no significant within-group change in BTMs after three months in both study arms. CONCLUSION: Supplementation with daily 200 mg of flavanols during three months, on top of usual care in individuals with T2DM, did not result in changes in BTMs compared to placebo. Future studies are needed to show whether long-term supplementation in higher dosages may positively affect BTMs in individuals with T2DM.

Original language	English
Pages (from-to)	51-60
Number of pages	10
Journal	Nutrition and Healthy Aging
Volume	7
Issue number	1-2
DOIs	https://doi.org/10.3233/NHA-220157
Publication status	Published - 6 Oct 2022

Bibliographical note

Funding statement
The Jaap Schouten Foundation, Rotterdam, The
Netherlands, kindly provided funding for investigating the role of Advanced Glycation End Products in
musculoskeletal health and participation in this trial.
The funding source had no role in the study design,
conducting the experiments, data analysis, interpretation, writing of the report, or decision to submit the
article for publication.

Publisher Copyright:
© 2022 - The authors. Published by IOS Press.

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Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus–post hoc analysis from a 3-month randomized placebo-controlled triaFinal published version, 198 KBLicence: CC BY-NC

Cite this

@article{9f67fa3af01a420c857db3d565aeaade,

title = "Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus-post hoc analysis from a 3-month randomized placebo-controlled trial",

abstract = "BACKGROUND: Individuals with type 2 diabetes mellitus (T2DM) have increased fracture risk with high bone mineral density, possibly related to advanced glycation end products (AGEs) accumulation in bone. Flavanol supplementation in postmenopausal women reduced AGEs formation and decreased bone resorption markers. However, to date, these effects have not been investigated in T2DM. OBJECTIVE: We used a post hoc secondary analysis to determine the effect of monomeric and oligomeric flavanols supplementation on bone turnover markers (BTMs) in individuals with T2DM. METHODS: Eighty-three individuals with T2DM, aged 40-85 years, with microalbuminuria were enrolled from 4 trial centers in Rotterdam, the Netherlands, into a randomized, double-blind, placebo-controlled trial with renal vascular health as the primary outcome. Participants were randomized (1:1) to receive either a placebo or 200 mg of monomeric and oligomeric flavanols as intervention for three months. Serum alkaline phosphatase (ALP), type I collagen crosslinked beta C-telopeptide (β-CTx), and type I procollagen-N-propeptide (P1NP) were measured at baseline and three months. ANCOVA was performed on rank transformed BTMs at three months as the outcome, adjusting for baseline BTMs, group, age, sex, and BMI. RESULTS: Baseline characteristics did not differ between the two arms. The adjusted mean change in BTMs at three months was not different between the placebo vs. intervention arm: ALP -0.059 (-0.262-0.145) vs. 0.060 (-0.135-0.356), p = 0.41; β-CTx 0.013 (-0.205-0.231) vs. 0.100 (-0.109-0.310), p = 0.53 and P1NP 0.091 (-0.080-0.262) vs. 0.030 (-0.134-0.195), p = 0.61. There was no significant within-group change in BTMs after three months in both study arms. CONCLUSION: Supplementation with daily 200 mg of flavanols during three months, on top of usual care in individuals with T2DM, did not result in changes in BTMs compared to placebo. Future studies are needed to show whether long-term supplementation in higher dosages may positively affect BTMs in individuals with T2DM.",

author = "Komal Waqas and Mardin Rashid and {Van Der Eerden}, {Bram C.J.} and {Van Den Berg}, {Sjoerd A.A.} and Sijbrands, {Eric J.G.} and Berk, {Kirsten A.} and Zillikens, {M. Carola}",

note = "Funding statement The Jaap Schouten Foundation, Rotterdam, The Netherlands, kindly provided funding for investigating the role of Advanced Glycation End Products in musculoskeletal health and participation in this trial. The funding source had no role in the study design, conducting the experiments, data analysis, interpretation, writing of the report, or decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2022 - The authors. Published by IOS Press.",

year = "2022",

month = oct,

day = "6",

doi = "10.3233/NHA-220157",

language = "English",

volume = "7",

pages = "51--60",

journal = "Nutrition and Healthy Aging",

issn = "2451-9480",

publisher = "IOS Press BV",

number = "1-2",

}

TY - JOUR

T1 - Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus-post hoc analysis from a 3-month randomized placebo-controlled trial

AU - Waqas, Komal

AU - Rashid, Mardin

AU - Van Der Eerden, Bram C.J.

AU - Van Den Berg, Sjoerd A.A.

AU - Sijbrands, Eric J.G.

AU - Berk, Kirsten A.

AU - Zillikens, M. Carola

N1 - Funding statement The Jaap Schouten Foundation, Rotterdam, The Netherlands, kindly provided funding for investigating the role of Advanced Glycation End Products in musculoskeletal health and participation in this trial. The funding source had no role in the study design, conducting the experiments, data analysis, interpretation, writing of the report, or decision to submit the article for publication. Publisher Copyright: © 2022 - The authors. Published by IOS Press.

PY - 2022/10/6

Y1 - 2022/10/6

N2 - BACKGROUND: Individuals with type 2 diabetes mellitus (T2DM) have increased fracture risk with high bone mineral density, possibly related to advanced glycation end products (AGEs) accumulation in bone. Flavanol supplementation in postmenopausal women reduced AGEs formation and decreased bone resorption markers. However, to date, these effects have not been investigated in T2DM. OBJECTIVE: We used a post hoc secondary analysis to determine the effect of monomeric and oligomeric flavanols supplementation on bone turnover markers (BTMs) in individuals with T2DM. METHODS: Eighty-three individuals with T2DM, aged 40-85 years, with microalbuminuria were enrolled from 4 trial centers in Rotterdam, the Netherlands, into a randomized, double-blind, placebo-controlled trial with renal vascular health as the primary outcome. Participants were randomized (1:1) to receive either a placebo or 200 mg of monomeric and oligomeric flavanols as intervention for three months. Serum alkaline phosphatase (ALP), type I collagen crosslinked beta C-telopeptide (β-CTx), and type I procollagen-N-propeptide (P1NP) were measured at baseline and three months. ANCOVA was performed on rank transformed BTMs at three months as the outcome, adjusting for baseline BTMs, group, age, sex, and BMI. RESULTS: Baseline characteristics did not differ between the two arms. The adjusted mean change in BTMs at three months was not different between the placebo vs. intervention arm: ALP -0.059 (-0.262-0.145) vs. 0.060 (-0.135-0.356), p = 0.41; β-CTx 0.013 (-0.205-0.231) vs. 0.100 (-0.109-0.310), p = 0.53 and P1NP 0.091 (-0.080-0.262) vs. 0.030 (-0.134-0.195), p = 0.61. There was no significant within-group change in BTMs after three months in both study arms. CONCLUSION: Supplementation with daily 200 mg of flavanols during three months, on top of usual care in individuals with T2DM, did not result in changes in BTMs compared to placebo. Future studies are needed to show whether long-term supplementation in higher dosages may positively affect BTMs in individuals with T2DM.

AB - BACKGROUND: Individuals with type 2 diabetes mellitus (T2DM) have increased fracture risk with high bone mineral density, possibly related to advanced glycation end products (AGEs) accumulation in bone. Flavanol supplementation in postmenopausal women reduced AGEs formation and decreased bone resorption markers. However, to date, these effects have not been investigated in T2DM. OBJECTIVE: We used a post hoc secondary analysis to determine the effect of monomeric and oligomeric flavanols supplementation on bone turnover markers (BTMs) in individuals with T2DM. METHODS: Eighty-three individuals with T2DM, aged 40-85 years, with microalbuminuria were enrolled from 4 trial centers in Rotterdam, the Netherlands, into a randomized, double-blind, placebo-controlled trial with renal vascular health as the primary outcome. Participants were randomized (1:1) to receive either a placebo or 200 mg of monomeric and oligomeric flavanols as intervention for three months. Serum alkaline phosphatase (ALP), type I collagen crosslinked beta C-telopeptide (β-CTx), and type I procollagen-N-propeptide (P1NP) were measured at baseline and three months. ANCOVA was performed on rank transformed BTMs at three months as the outcome, adjusting for baseline BTMs, group, age, sex, and BMI. RESULTS: Baseline characteristics did not differ between the two arms. The adjusted mean change in BTMs at three months was not different between the placebo vs. intervention arm: ALP -0.059 (-0.262-0.145) vs. 0.060 (-0.135-0.356), p = 0.41; β-CTx 0.013 (-0.205-0.231) vs. 0.100 (-0.109-0.310), p = 0.53 and P1NP 0.091 (-0.080-0.262) vs. 0.030 (-0.134-0.195), p = 0.61. There was no significant within-group change in BTMs after three months in both study arms. CONCLUSION: Supplementation with daily 200 mg of flavanols during three months, on top of usual care in individuals with T2DM, did not result in changes in BTMs compared to placebo. Future studies are needed to show whether long-term supplementation in higher dosages may positively affect BTMs in individuals with T2DM.

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U2 - 10.3233/NHA-220157

DO - 10.3233/NHA-220157

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AN - SCOPUS:85140853736

SN - 2451-9480

VL - 7

SP - 51

EP - 60

JO - Nutrition and Healthy Aging

JF - Nutrition and Healthy Aging

IS - 1-2

ER -

Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus-post hoc analysis from a 3-month randomized placebo-controlled trial

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