Natural Versus Synthetic Vitamin B Complexes in Human

NCT03444155 | Completed Results

• 1 other identifier: Medical University of Graz
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex) (Pan \[Greek\] = all; moles \[Latin\] = molecules/particles - brand name) versus synthetic vitamin B complexes to identify the bioavailability of distinct vitamins as well as long-term effects. The primary hypothesis for this study: "Natural Vitamin B-complexes are as effective as synthetic Vitamin B-complexes or better." For this reason 30 subjects (18 to 65y; BMI \>19 to \<29) were recruited for this study. The study population was divided into 2 groups of each 15 subjects in a cross-over trial. Vitamin supplementation consisted of Thiamine (2.93 mg), Riboflavin (3.98 mg), Niacin (29.85 mg), Pantothenic acid (10.95 mg), Pyridoxine (3.38 mg), Biotin (0.108 mg), Folic acid (0.69 mg) and Cobalamin (8.85 µg) per day in both groups. Blood samples are taken at baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - wash out phase I (2 weeks); start cross-over: baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - washout phase II (6 weeks). In case of main target criteria Thiamin, Riboflavin, Pyridoxine, Folic acid and Cobalamin were measured in serum as well as total peroxides (µmol/L), peroxidase-activity (U/L), total antioxidant status (mmol/L) and polyphenols (mmol/L).

Conditions

Healthy; Thiamine and Niacin Deficiency States; Pyridoxine Deficiency; Folic Acid Deficiency Anemia, Dietary; Vitamin B 12 Deficiency; Peroxidase; Defect; Polyphenols; Oxidative Stress; Homocystine; Metabolic Disorder

Outcome Measures

Primary Outcomes (5)

• Serum Thiamine

  Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98

  20 weeks

• Serum Riboflavin

  Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341

  20 weeks

• Serum Pyridoxine

  Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8

  20 weeks

• Serum Folic Acid

  Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10

  20 weeks

• Serum Cobalamin

  Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230

  20 weeks

Secondary Outcomes (5)

• Serum Total Peroxides

  20 weeks

• Serum Total Antioxidant Capacity

  20 weeks

• Serum Endogenous Peroxidase-activity

  20 weeks

• Serum Polyphenols

  20 weeks

• Total Homocysteine

  20 weeks

Study Arms (2)

Natural Panmol-B-Complex first, then synthetic Vitamin B-complex

ACTIVE COMPARATOR

Participants first received a Natural Vitamin B-complex, i.e., Panmol-B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a synthetic Vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.The study finished after the second wash-out period for another 6 weeks.

Dietary Supplement: Natural Panmol-B-Complex

Synthetic Vitamin B-complex first, then Natural Panmol-B-Complex

ACTIVE COMPARATOR

Participants first received a Synthetic Vitamin B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks. After a wash-out period of 2 weeks, they then received a natural Vitamin B-complex, i.e., Panmol-B-complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) daily each morning for 6 weeks.The study finished after the second wash-out period for another 6 weeks.

Dietary Supplement: Synthetic Vitamin B-Complex

Interventions

Natural Panmol-B-Complex DIETARY_SUPPLEMENT

Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) - Synthetic Vitamin B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)

Natural Panmol-B-Complex first, then synthetic Vitamin B-complex

Synthetic Vitamin B-Complex DIETARY_SUPPLEMENT

Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) - Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)

Synthetic Vitamin B-complex first, then Natural Panmol-B-Complex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female
• Healthy

You may not qualify if:

• Cholesterol \>240mg/dl
• Pregnancy and lactation period
• Clinical diagnosis of chronic infections
• Ingestion of trace elements, vitamin- and fatty acid supplements in the past 3 months
• Clinical diagnosis of cardiovascular disease
• Clinical diagnosis of cancer
• Clinical diagnosis of psychotic diseases
• Insulin dependent diabetes
• Clinical diagnosis of autoimmune diseases
• Maldigestion/Malabsorption
• Veganes cuisine
• \> 1 Beer/day

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Wonisch Willibald

Graz, Styria, 8036, Austria

Location

Related Publications (2)

• Lindschinger M, Tatzber F, Schimetta W, Schmid I, Lindschinger B, Cvirn G, Stanger O, Lamont E, Wonisch W. A Randomized Pilot Trial to Evaluate the Bioavailability of Natural versus Synthetic Vitamin B Complexes in Healthy Humans and Their Effects on Homocysteine, Oxidative Stress, and Antioxidant Levels. Oxid Med Cell Longev. 2019 Dec 12;2019:6082613. doi: 10.1155/2019/6082613. eCollection 2019.

  PMID: 31915511 RESULT

• Lindschinger M, Tatzber F, Schimetta W, Schmid I, Lindschinger B, Cvirn G, Fuchs N, Markolin G, Lamont E, Wonisch W. [Bioavailability of natural versus synthetic B vitamins and their effects on metabolic processes]. MMW Fortschr Med. 2020 Mar;162(Suppl 4):17-27. doi: 10.1007/s15006-020-0230-4. Epub 2020 Mar 19. German.

  PMID: 32189314 RESULT

MeSH Terms

Conditions

Vitamin B 6 Deficiency; Vitamin B 12 Deficiency; Metabolic Diseases

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Willibald Wonisch
• Organization: Otto Loewi Research Center, Chair of Physiological Medicine, Medical University of Graz, Austria

willibald.wonisch@medunigraz.at

00436505299540

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking was organized and supervised by the randomization person in charge. Group assignment was 1:1 (control vs. verum group) with identical packages for both Vitamin supplements with 126 capsules for each subject per phase. Randomization was done with sealed envelopes.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Vitamin B complex (natural vs. synthetic) administered in capsules each day for 6 weeks - 2 weeks wash-out phase I (2 weeks) - cross-over 6 weeks - wash-out phase II (6 weeks)

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 23, 2018
• Study Start: May 8, 2017
• Primary Completion: October 3, 2017
• Study Completion: November 17, 2017
• Last Updated: April 26, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-04

Locations

AU (1)